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| fda approved til therapy: Rheumatic Diseases and Syndromes Induced by Cancer Immunotherapy Maria E. Suarez-Almazor, Leonard H. Calabrese, 2021-02-16 With the increasing use of immune checkpoint inhibitors (ICI) across various cancers, the trends for indication at earlier stages, and the use of combination immunotherapy, the frequency of ICI-induced immune-related adverse events (irAE) is expected to grow substantially. Management of these irAE is challenging as it requires not only consideration of the toxicity but also risk-benefit ratios with respect to the primary cancer. Several rheumatic irAE have been reported with ICI therapy including arthritis, myositis, polymyalgia-like syndromes, sicca/Sjogren-like manifestations, and several other less common systemic autoimmune features commonly associated with connective tissue disease. This handbook provides clinicians with a comprehensive overview of the management of rheumatic irAE that develop from cancer immunotherapy. It focuses on the irAE seen with ICI, the most frequently used agents in treating cancer. It provides an overview of cancer immunology, immunotoxicity, and immunotherapies such as ICI, cytokine-based therapy, and CART. It examines the epidemiology, clinical manifestations, diagnosis, differential diagnosis, and treatment of a variety of rheumatic immune-related adverse events arising from these therapies. Chapters also cover cancer immunotherapy in patients with preexisting rheumatic diseases such as inflammatory arthritis and other connective tissue disorders. The book helps clinicians to distinguish the current types of cancer immunotherapy and general toxicity patterns, recognize and diagnose rheumatic clinical syndromes, understand the pathogenesis of irAE, and consider risk–benefit ratios when managing patients with rheumatic irAE. Rheumatic Diseases and Syndromes Induced by Cancer Immunotherapy is an essential resource for physicians and related professionals, residents, fellows, graduate students and nurses alike in rheumatology, clinical immunology, oncology, and internal medicine. |
| fda approved til therapy: The Basics of Cancer Immunotherapy Haidong Dong, Svetomir N. Markovic, 2018-01-05 This book provides patients and their physicians (especially “non-oncologist” health care providers) with a clear and concise introduction to cancer immunotherapy, which, unlike traditional forms of cancer therapy, acts by boosting the patient’s own immune system to fight cancer. The unique features of cancer immunotherapy make its management, monitoring and side-effects different from those of traditional cancer therapy. Especially novel are the side effects of cancer immunotherapy, necessitating greater awareness for both patients and physicians in order to minimize complications of therapy. The patient-friendly, concise, easy-to-understand, and up-to-date knowledge presented in this book will inform patients about the benefits and risks of cancer immunotherapy, and help them and their care providers to understand how immunotherapy would control their unique disease. Researchers and academic professionals in the field of cancer immunotherapy will also find clear and useful information to help them communicate with patients or address unresolved problems. Some key features of the book are: Expertise. All editors and authors are scientists and oncologists specializing in cancer immunotherapy, and are involved in scientific discovery from the early stage of immune-checkpoint inhibitors to today’s daily patient care. Their insights, expertise and experience guarantee the high quality and authority in the science, medicine and practice of cancer immunotherapy. Patient-friendly. This book is written for cancer patients in order to meet their needs when considering immunotherapy. As an educational tool, this book will help the reader balance the risks and benefits based on both science and clinical facts, and therefore to make the best choice in receiving or withdrawing from immunotherapy. Disease Specificity. Cancer is a complicated disease involving multiple stages and pathology. Its response to immunotherapy is individualized and varies depending on cancer types. The authors’ expertise in treating different types of cancers, including melanoma, lung, kidney, bladder, and lymphoma, provides disease-specific insights in applying immunotherapy to each disease. |
| fda approved til therapy: CAR-T Cell Therapies for Non-Hematopoietic Malignancies: Taking Off The Training Wheels Avery Dexter Posey, Jr., John - Maher, Marcela V. Maus, 2020-04-24 Chimeric antigen receptor (CAR) T cell therapies for leukemia (e.g. tisagenlecleucel) and lymphoma (e.g. axicabtagene ciloleucel) have recently received regulatory approval in the United States. Phase I/II trials have demonstrated complete remission of refractory or relapsed tumors in 50% - 94% patients. However, the clinical successes of engineered T cells for the treatment of solid malignancies have thus far been few and far between. Furthermore, several instances of severe and lethal toxicities have arisen due to on-target, off-tumor recognition of antigen by T cell products. Recent advances in phase I trials for solid tumors, as well as in pre-clinical models, have revealed several variables that will be important to consider for the successful use of CAR-T cells in treating solid tumors. These variables include (i) regional versus systemic delivery; (ii) scFv versus ligand interactions; (iii) antigen loss versus escape; (iv) epitope spreading and (v) checkpoint expression on immune cells or tumor cells. Also, there remains outstanding mechanistic questions related to why differences exist in the persistence and tonic signaling of second-generation CD28 versus 4-1BB co-stimulated CAR-T cells. In addition, we are now learning the roles of lympho-depleting regimens (and associated toxicities) in modifying the persistence of engineered T cell therapies. A more comprehensive view of CAR-T cell strategies and important advances, both of pre-clinical and clinical evaluations, in solid tumors is necessary to drive these therapies forward. |
| fda approved til therapy: Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, 2020-04-24 Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events. |
| fda approved til therapy: Gene and Cellular Immunotherapy for Cancer Armin Ghobadi, John F. DiPersio, 2022-01-01 Clinical and preclinical exploration of gene and cellular immunotherapy have seen rapid growth and interest with the development and approval of five Chimeric Antigen Receptor T-cell (CAR-T) products for lymphoma and myeloma and one Bispecific T-Cell Engager (BiTE) for acute lymphoblastic leukemia (ALL). These advances have dramatically improved the management of patients with relapsed refractory lymphoma, myeloma and leukemia. Gene and Cellular Immunotherapy for Cancer offers readers a comprehensive review of current cellular and gene-based immunotherapies. Divided into eighteen cohesive chapters, this book provides an in-depth and detailed look into cellular-based immunotherapies including CAR-T, TCR-T, TIL, Viral CTLs, NK cells in addition to T/NK cell engagers, focusing on their historical perspectives, biology, development and manufacturing, toxicities and more. Edited by two leading experts on gene and cellular immunotherapy, the book will feature chapters written by a diverse collection of recognized and up-and-coming experts and researchers in the field, providing oncologists, immunologists, researchers and clinical and basic science trainees with a bench to bedside view of the latest developments in the field. |
| fda approved til therapy: Advances in Precision Medicine Oncology Hilal Arnouk, Bassam Abdul Rasool Hassan, 2021 Recent advances in precision medicine and immuno-oncology have led to highly specific and efficacious cancer therapies such as monoclonal antibodies and immune checkpoint inhibitors (ICIs). This book provides an up-to-date overview of advances in the field of immuno-oncology. Chapters cover such topics as ICIs and how they mount a robust immune response against cancer cells as well as the response of ICIs to treatment predictive biomarkers and their potential immune-related adverse events (irAEs). Additionally, the book includes a comprehensive review of the powerful FDA-approved therapeutic agent doxorubicin, highlighting the molecular mechanisms behind doxorubicin's drug resistance and critical side effects. |
| fda approved til therapy: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| fda approved til therapy: The Washington Manual Hematology and Oncology Subspecialty Consult Brian A. Van Tine, Meagan A. Jacoby, 2024-10-02 Concise, portable, and user-friendly, The Washington Manual Hematology and Oncology Subspecialty Consult, 5th Edition, provides quick access to the essential information needed to evaluate a patient on a hematology-oncology subspecialty consult service. Edited by Drs. Brian A. Van Tine and Meagan A. Jacoby, this best-selling manual offers state-of-the-art content, including coverage of new therapies such as CAR T-cell therapy, new anti-cancer drugs, and new biomarkers and therapeutic targets. Ideal for fellows, residents, and medical students rotating on hematology and oncology subspecialty services, the manual is also useful as a first-line resource for advanced practice providers, general internal medicine physicians, Hem/ONC fellows, and other primary care providers. |
| fda approved til therapy: Targeted Therapeutics in Melanoma Thomas F. Gajewski, F. Stephen Hodi, 2011-12-15 Melanoma is an increasingly important public health problem. Although the cause of most malignant melanomas – over-exposure to ultraviolet light – is well known, effective treatment has remained challenging. The past several years have been marked by extraordinary developments in melanoma treatment in the arena of targeted therapeutics. This book describes these ground-breaking discoveries and their implications for clinical use. As melanoma biology is increasingly understood, so the development of targeted therapies for this disease is spurred ahead. This book covers both established signal transduction inhibitors and the fascinating emerging realm of molecularly-guided immunotherapies. This benchmark book provides the most up-to-date information on the new breed of melanoma therapies. Composed of the works of major researchers and clinicians, this book offers new insights, novel approaches, and promising data for effective treatment planning. Illuminating the latest advances in the field, it is a solid resource for clinical oncologists, translational scientists, and basic cancer researchers. |
| fda approved til therapy: The Washington Manual of Oncology Ramaswamy Govindan, Daniel Morgensztern, Armin Ghobadi, 2020-11-05 Focusing on the essential information you need to know for the clinical practice of oncology, this practical volume in the Lippincott Manual series provides concise, high-yield content that reflects today’s fast-changing advances in the field. In one convenient, portable resource, you’ll find complete coverage of cancer management, all at your fingertips for quick review and reference. The Washington Manual® of Oncology, 4th Edition, is an ideal reference for oncologists, residents, fellows, medical students, nurse practitioners, and physician assistants. |
| fda approved til therapy: New Therapies and Immunological Findings in Melanoma and Other Skin Cancers Atsushi Otsuka, Reinhard Georg Dummer, 2019-01-15 New therapies are currently being developed in the field of skin cancer. In particular, advances in melanoma now represent the frontline of cancer immunotherapy, as immunological findings in the disease have led to the development of highly effective immune-checkpoint inhibitors. However, these immune-checkpoint inhibitors are only effective in a subset of patients, and may not work in other skin cancer types, thus highlighting the need for further innovation in the field of skin cancer treatment. The purpose of this Research Topic is therefore to provide an up-to-date overview of immune processes and new therapies for melanoma and other skin cancers in order to further stimulate the development of new and even more successful treatments. |
| fda approved til therapy: Lung Cancer Karen L. Reckamp, 2016-08-17 This book describes the molecular mechanisms of lung cancer development and progression that determine therapeutic interventions in the era of genomics, when the rapid evolution in lung cancer diagnosis and treatment necessitates critical review of new results to integrate advances into practice. The text opens with background and emerging information regarding the molecular biology of lung cancer pathogenesis. Updated results regarding lung cancer prevention and screening are discussed, followed by chapters on diagnostic techniques and pathological evaluation. This leads on to a detailed presentation of treatment modalities, from surgery and radiation therapy to standard chemotherapy and targeted agents. The coverage includes resistance to therapy and the emergence of immunotherapy for lung cancer; in addition, the current evidence in respect of small cell lung cancer is summarized. The book presents insights from experts across disciplines to emphasize the importance of collaborative care. Advances in our understanding of issues in geriatric oncology and palliative care complete the comprehensive discussion of lung cancer. |
| fda approved til therapy: FDA Consumer , 2000 |
| fda approved til therapy: Vaccines for Cancer Immunotherapy Nima Rezaei, Mahsa Keshavarz-Fathi, 2018-10-17 Therapeutic cancer vaccines represent a type of active cancer immunotherapy. Clinicians, scientists, and researchers working on cancer treatment require evidence-based and up-to-date resources relating to therapeutic cancer vaccines. Vaccines for Cancer Immunotherapy provides a reference for cancer treatment for clinicians and presents a well-organized resource for determining high-potential research areas. The book considers that this promising modality can be made more feasible as a treatment for cancer. Chapters cover cancer immunology, general approaches to cancer immunotherapy, vaccines, tumor antigens, the strategy of allogeneic and autologous cancer vaccines, personalized vaccines, whole-tumor antigen vaccines, protein and peptide vaccines, dendritic cell vaccines, genetic vaccines, candidate cancers for vaccination, obstacles to developing therapeutic cancer vaccines, combination therapy, future perspectives and concluding remarks on therapeutic cancer vaccines. - Introduces the feasible immunotherapeutic vaccines for patients with different types of cancer - Presents the status of past and current vaccines for cancer treatment - Considers advantages and disadvantages of different therapeutic cancer vaccines - Looks at the combination of vaccines and other modalities, including immunotherapeutic and conventional methods - Analyzes obstacles to development of therapeutic cancer vaccines - Gives a view on future perspectives in the application of therapeutic cancer vaccines |
| fda approved til therapy: Immunotherapy of Hepatocellular Carcinoma Tim F. Greten, 2018-08-22 In this book we provide insights into liver – cancer and immunology. Experts in the field provide an overview over fundamental immunological questions in liver cancer and tumorimmunology, which form the base for immune based approaches in HCC, which gain increasing interest in the community due to first promising results obtained in early clinical trials. Hepatocellular carcinoma (HCC) is the third most common cause of cancer related death in the United States. Treatment options are limited. Viral hepatitis is one of the major risk factors for HCC, which represents a typical “inflammation-induced” cancer. Immune-based treatment approaches have revolutionized oncology in recent years. Various treatment strategies have received FDA approval including dendritic cell vaccination, for prostate cancer as well as immune checkpoint inhibition targeting the CTLA4 or the PD1/PDL1 axis in melanoma, lung, and kidney cancer. Additionally, cell based therapies (adoptive T cell therapy, CAR T cells and TCR transduced T cells) have demonstrated significant efficacy in patients with B cell malignancies and melanoma. Immune checkpoint inhibitors in particular have generated enormous excitement across the entire field of oncology, providing a significant benefit to a minority of patients. |
| fda approved til therapy: Adoptive cellular therapies in immunoregulation and cancer "Patrick" Peishun Shou, Chunliang Xu, Song Zhang, 2023-07-05 |
| fda approved til therapy: Colorectal Cancer Liver Metastases Mauro Monteiro Correia, Michael A. Choti, Flavio G. Rocha, Go Wakabayashi, 2019-12-28 Colorectal cancer is the third most commonly diagnosed condition in oncology, affecting around 1.23 million individuals per year, according to recent statistics. Of these patients, about 50% will develop liver metastases and approximately 20% will present a stage IV disease at diagnosis. These statistics make colorectal liver metastases (CLM) an issue of major importance in current oncology. The area of CLM is subject to great and continuous advances, as its pathophysiologic mechanisms are better understood and more therapeutic and surgical options are developed. Consequently, all professionals involved with the diagnosis, treatment and follow up of CLM should be kept up to date with the latest advances on the field, to provide high standard medical care to their patients. This book is designed to present the state-of-the-art in CLM management and, in doing so, to review the current evidence on CLM, discussing all important topics in the field. Coverage is broad and comprehensive, encompassing introductory topics (history, definitions, epidemiology, etc.), basic science subjects (molecular biology, genetics, dissemination process, etc.) and practical clinical topics (tumor behavior, diagnosis, drug therapy, radiation therapy, surgery, ablation, multidisciplinary teams, etc.). Although comprehensive on the coverage and selection of topics, each chapter is concise and objective, dissecting topics in a practical and direct format. Evidences and recommendations are included. Chapters display a brief introduction of the common knowledge, go straight to the detailed revision of the most recent years of the literature, and end with practical closing observations. This book is a tool for professionals (general and cancer surgeons, HPB surgeons, clinical oncologists, gastroenterologists and medical residents) and interns who search for a qualified and reader friendly revision on topics concerning Colorectal Cancer Liver Metastases. |
| fda approved til therapy: Malignant Vinayak K. Prasad, 2020-04-21 This well-written, opinionated, and engaging book explains what we can do differently to make serious and sustained progress against cancer—and how we can avoid repeating the policy and practice mistakes of the past. |
| fda approved til therapy: Co-signal Molecules in T Cell Activation Miyuki Azuma, Hideo Yagita, 2019-11-22 This book equips young immunologists and health professionals with a clear understanding of the fundamental concepts and roles of co-signal molecules and in addition presents the latest information on co-stimulation. The first part of the book is devoted to co-signal molecules and the regulation of T cells. Following an initial overview, subsequent chapters examine each co-signal molecule in turn and discuss the mechanisms by which co-signal molecules regulate the different types of T cell. The second part covers various clinical applications, including in autoimmune disease, neurological disorders, transplantation, graft-versus-host disease, and cancer immunotherapy. To date, co-stimulation blockade and co-inhibition blockade have shown beneficial effects and many additional clinical trials targeting co-signal molecules are ongoing. The mechanisms underlying these successful treatments are explained and the future therapeutic potential in the aforementioned diseases is evaluated. Co-signal Molecules in T Cell Activation will be a valuable reference guide to co-stimulation for basic and clinical researchers in the fields of both immunology and pharmaceutical science. |
| fda approved til therapy: Melanoma Adam I. Riker, 2018-06-06 This text serves as a very useful clinical guide and realistic approach to the clinical management of melanoma. Primary care physicians, specialists from varying areas of medical practice and numerous other healthcare providers will find this text to be quite useful as a standard daily reference and use in the office setting. It provides a clear and concise source of information in order to make real-life, evidence-based decisions for all aspects of management for cutaneous melanoma. This book also provides the latest breakthroughs in melanoma research, ranging from recent discoveries in genomics and epigenetics, to newly identified genes that have been selectively targeted for the development of a personalized approach to treatment. All chapters are written by specialists and true experts within their respective fields, incorporating the latest scientific, clinical and evidence-based medicine for melanoma (and non-melanoma skin cancers). This up-to-date information can be easily applied and translated to the clinical setting for the melanoma patient. |
| fda approved til therapy: Chemistry and Pharmacology of Anticancer Drugs David E. Thurston, Ilona Pysz, 2021-03-18 While drug therapies developed in the last 80 years have markedly improved treatment outcomes and the management of some types of cancers, the lack of effectiveness and side effects associated with the most common treatment types remain unacceptable. However, recent technological advances are leading to improved therapies based on targeting distinct biological pathways in cancer cells. Chemistry and Pharmacology of Anticancer Drugs is a comprehensive survey of all families of anticancer agents and therapeutic approaches currently in use or in advanced stages of clinical trials, including biological-based therapies. The book is unique in providing molecular structures for all anticancer agents, discussing them in terms of history of development, chemistry, mechanism of action, structure–function relationships, and pharmacology. It also provides relevant information on side effects, dosing, and formulation. The authors, renowned scientists in cancer research and drug discovery, also provide up-to-date information on the drug discovery process, including discussions of new research tools, tumor-targeting strategies, and fundamental concepts in the relatively new areas of precision medicine and chemoprevention. Chemistry and Pharmacology of Anticancer Drugs is an indispensable resource for cancer researchers, medicinal chemists and other biomedical scientists involved in the development of new anticancer therapies. Its breadth of coverage, clear explanations, and illustrations also make it suitable for undergraduate and postgraduate courses in medicine, pharmacy, nursing, dentistry, nutrition, the biomedical sciences, and related disciplines. Key Features: Summarizes the fundamental causes of cancer, modes of treatment, and strategies for cancer drug discovery Brings together a broad spectrum of information relating to the chemistry and pharmacology of all families of anticancer agents and therapies Includes up-to-date information on cutting-edge aspects of cancer treatments such as biomarkers, pharmacogenetics, and pharmacogenomics Features new chapters on the Evolution of Anticancer Therapies, Antibody-Based Therapies, and Cancer Chemoprevention |
| fda approved til therapy: Cancer Immunotherapy and Biological Cancer Treatments Hilal Arnouk, 2019-11-13 In recent years, biological cancer therapies, including immunotherapy, have moved from the bench to mainstream medical treatments of several types of cancer. The success of these treatments relies on innovative approaches to specifically interfere with molecular targets that are involved in the growth, progression, and spread of malignant cells, or to bypass the tumor evasion of the immune system utilizing the latest advances in cancer vaccine development, formulation, and delivery. This book presents an up-to-date overview of novel cancer biological and immunotherapeutic approaches, including cancer vaccines, mimetic vaccines, monoclonal antibodies, adoptive T-cell transfer, chimeric antigen receptor T- cells, tumor infiltrating lymphocytes, dendritic cells, natural killer cells, immune checkpoint inhibitors, laser ablation, and immune stimulating interstitial laser thermotherapy. |
| fda approved til therapy: Cancer Immunotherapies: From Efficacy to Resistance Mechanisms Morten Hansen, Janin Chandra, Fernando Guimaraes, Nicolas Jacquelot, Yoshinobu Koguchi, Nathalie Labarriere, Ilaria Marigo, Lazar Vujanovic, 2022-06-29 Dr. Koguchi receives funding from Tesaro, a GSK company, Bristol-Myers Squibb, and Shimadzu Corporation.. Dr. Vujanovic is a co-inventor of a methodology licensed to INmune Bio, Inc. where a selective inhibitor of soluble TNF can be used to prevent or treat malignancies. Dr. Hansen is the recipient of a private grant from Eurostars Eureka. The other Topic Editors declare no competing interests. |
| fda approved til therapy: Pharmaceutics Alekha Dash, Somnath Singh, 2023-09-13 Pharmaceutics: Basic Principles and Application to Pharmacy Practice, Second Edition is a valuable textbook covering the role and application of pharmaceutics within pharmacy practice. This updated resource is geared toward meeting and incorporating the current curricular guidelines on pharmaceutics and laboratory skills mandated by the American Council for Pharmacy Education. It includes a number of student-friendly features, including chapter objectives and summaries, practical examples, case studies, numerous images and key-concept text boxes. Two new chapters are included, as well as a new end of chapter section covering critical reflections and practice applications. Divided into three sections – Physical Principles and Properties of Pharmaceutics; Practical Aspects of Pharmaceutics; and Biological Applications of Pharmaceutics – this new edition covers all aspects of pharmaceutics and providing a single and compelling source for students. - Facilitates an integrated and extensive coverage of the study of pharmaceutics due to the clear and engaging language used by the authors - Includes chapter objectives and summaries to illustrate and reinforce key ideas - Meets curricular guidelines for pharmaceutics and laboratory skills mandated by the Accreditation Council for Pharmacy Education (ACPE) - Includes new practice questions, answers, and case studies for experiential learning |
| fda approved til therapy: Cutaneous Oncology, An Issue of Hematology/Oncology Clinics of North America, E-Book David E. Fisher, 2024-09-05 In this issue of Hematology/Oncology Clinics, guest editor Dr. David E. Fisher brings his considerable expertise to the topic of Cutaneous Oncology. Top experts first provide information on skin structure, function, and immunology, then offer overviews of the therapeutic state of the art for both melanoma and non-melanoma skin cancers. Discussions focus on unique clinical challenges and biological breakthroughs which have come to light in recent studies of cutaneous malignancies. - Contains 16 relevant, practice-oriented topics including high risk non-melanoma skin cancers; progress in immune checkpoints for melanoma therapy; targeted therapy innovations for melanoma; advances in vaccines for melanoma; microbiome and immunotherapy; Merkel cell carcinoma; and more. - Provides in-depth clinical reviews on cutaneous oncology, offering actionable insights for clinical practice. - Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews. |
| fda approved til therapy: Cancer Treatment: An Interdisciplinary Approach Nima Rezaei, 2024-01-01 Cancer treatment is a challenging issue, while the treatment modalities have extended from traditional surgery, chemotherapy, and radiation therapy to new therapeutic approaches, including targeted therapy, immunotherapy, stem cell transplantation, and hormone therapy. Therefore, an interdisciplinary approach is needed to find a better therapeutic protocols in order to increase the prognosis and quality of life of patients with cancer. The second volume of the “Interdisciplinary Cancer Research” series, entitled “Cancer Treatment: An Interdisciplinary Approach” publishes comprehensive volumes on different cancer treatment modalities and presents the most updated and peer-reviewed articles on cancer therapy. This interdisciplinary series is of special value to researchers and practitioners working on cell biology, immunology, hematology, biochemistry, genetics, oncology and related fields. This is the main concept of Cancer Immunology Project (CIP), which is a part of Universal Scientific Education and Research Network (USERN). This interdisciplinary book will be of special value for researchers and clinicians who wish to extend their knowledge on cancer treatment. |
| fda approved til therapy: The Health Effects of Cannabis and Cannabinoids National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda, 2017-03-31 Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€that summarizes and prioritizes pressing research needs. |
| fda approved til therapy: Accelerated Partial Breast Irradiation David E. Wazer, Douglas W. Arthur, Frank Vicini, 2009-08-11 Accelerated partial breast irradiation (APBI) is being rapidly introduced into the clinical management of early breast cancer. APBI, in fact, encompasses a number of different techniques and approaches that include brachytherapy, intraoperative, and external beam techniques. There is currently no single source that describes these techniques and their clinical implementation. This text is a concise handbook designed to assist the clinician in the implementation of APBI. This includes a review of the principles that underlie APBI, a practical and detailed description of each technique for APBI, a review of current clinical results of APBI, and a review of the incidence and management of treatment related complications. |
| fda approved til therapy: Biologics and Biosimilars Xiaodong Feng, Hong-Guang Xie, Ashim Malhotra, Catherine F. Yang, 2022-06-13 Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs. |
| fda approved til therapy: The Business of Healthcare Innovation Lawton Robert Burns, 2005-08-25 The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants. |
| fda approved til therapy: Melanoma, An Issue of Clinics in Plastic Surgery, E-Book Brian R. Gastman, Michael W. Neumeister, 2021-09-09 This issue of Clinics in Plastic Surgery, Guest Edited by Drs. Brian R. Gastman and Michael W. Neumeister, is dedicated to Melanoma. This issue is one of four selected each year. Articles in this issue include, but are not limited to: Melanoma risk factors and prevention, Biology and signaling pathways of melanoma, Immunobiology of melanoma, Clinical diagnosis and classification, Histopathologic and molecular diagnosis of melanoma, AJCC staging and other platforms to assess prognosis and risk, Current treatment guidelines of primary melanoma including wide excision and use of sentinel node biopsy, Dermatologic follow-up and assessment of suspicious lesions, Immunotherapy of melanoma, Targeted therapies for melanoma, Non-operative intra-tumoral therapies, Role of radiation for locoregional and distant metastatic melanoma, Adjuvant and neoadjuvant therapy for melanoma, Surgery of the nodal basins for trunk and extremity melanoma, Extirpative considerations of melanoma of the head and neck, Treatment of lentigo melanoma of the head and neck, Reconstructive considerations of melanoma of the head and neck, Melanoma of the hands and feet, Rare variants of melanoma, and Emerging therapies for melanoma. |
| fda approved til therapy: Successes and Challenges of NK Immunotherapy Benjamin Bonavida, Anahid Jewett, 2021-06-23 Successes and Challenges of NK Immunotherapy: Increasing Anti-tumor Efficacy describes the unique therapeutic applications of NK cells to fight cancers and eliminate the bulk and subset of cancer stem cells responsible for metastasis, relapse and recurrences. The book provides information on the development, engineering, mechanisms of action, response to various preclinical models, and applications in various clinical trials. Sections cover the development of highly engineered cytotoxic NK cells, their mechanisms of action, preclinical and clinical applications, the development and application of CAR-NK cells, and new NK-drug conjugates, also emphasizing that activated NK cells can target and kill highly resistant cancer stem cells. Written by the leading experts on NK immunotherapy worldwide, this is a valuable resource for researchers, clinicians and members of the biomedical field who are interested in understanding novel and efficient therapies to fight cancers. - Discusses the unique developmental applications of NK immunotherapy against cancers, which differs greatly from other types of immunotherapies - Provides up-to-date and highly relevant information through chapters written by the leading researchers in the field - Presents a significant number of schematic diagrams for easy understanding and reproducibility |
| fda approved til therapy: Conquering and Curing Cancer Charlene Seaman, Scott Seaman, 2021-10-07 Conquering And Curing Cancer – The Cancer Survival Book is focused on conquering and curing cancer. It is a patient's cancer survival guide. Part 1 takes you along with the authors from cancer diagnosis, surgery, chemotherapy, radiation therapy, follow-up treatments and testing, and provides the insights, fears, and triumphs of a cancer survivor and caregiver. Scott and Charlene ́s story of survivorship demystifies the experience and enlightens readers in a very humanistic and unique way. At Charlene ́s insistence, they turned their tragedy into a positive mission to help people impacted by cancer. Part 2 is focused on you - the steps and approach you should consider taking to survive cancer. It covers topics such as: (1) the basics about cancer; (2) selecting the best doctors and treatment centers available to you; (3) obtaining a prompt and proper diagnosis; (4) understanding medical tests and diagnostic tools; (5) surviving your hospital stay; (6) an overview of conventional treatments, novel treatments, and clinical trials; (7) selecting the best treatment option for your cancer in this age of personalized medicine; (8) understanding survival rates and making appropriate adjustments; (9) developing a cancer warrior mentality; (10) taking advantage of complementary therapies and a healthy lifestyle to help you beat the disease; (11) the role of the immune system in beating cancer, and the authors’ explanation as to why blood cancer research is the superhighway to curing cancer; (12) a national call to action to cure cancer; and (13) the impact of COVID-19. Part 3 is a patient’s survival compendium. This is a useful resource containing: a detailed listing of questions to ask your doctors at each critical phase; some tips doctors may forget to tell you; a checklist of legal and insurance documents; pointers on addressing the side effects of treatment; and a listing of organizations, web sites, and resources available to help you get the support and information you need about your type of cancer and the treatments and clinical trials available to you. It also includes a patient’s medical information workbook to help you record relevant information. The book is something you will want to bring with you so that you have important information at your fingertips. This book is all about conquering and conquering cancer. The authors wrote the book for cancer patients, survivors, caregivers, and families that they wished they had available to them when they embarked upon their cancer journey. |
| fda approved til therapy: The Duke Glioma Handbook Allan H. Friedman, 2016-03-31 Provides a summary of glioma biology, genetics and management, based on the world-leading Duke University Preston Robert Tisch Brain Tumor Center program. |
| fda approved til therapy: Oncoimmunology Laurence Zitvogel, Guido Kroemer, 2017-12-13 In this book, leading experts in cancer immunotherapy join forces to provide a comprehensive guide that sets out the main principles of oncoimmunology and examines the latest advances and their implications for clinical practice, focusing in particular on drugs with FDA/EMA approvals and breakthrough status. The aim is to deliver a landmark educational tool that will serve as the definitive reference for MD and PhD students while also meeting the needs of established researchers and healthcare professionals. Immunotherapy-based approaches are now inducing long-lasting clinical responses across multiple histological types of neoplasia, in previously difficult-to-treat metastatic cancers. The future challenges for oncologists are to understand and exploit the cellular and molecular components of complex immune networks, to optimize combinatorial regimens, to avoid immune-related side effects, and to plan immunomonitoring studies for biomarker discovery. The editors hope that this book will guide future and established health professionals toward the effective application of cancer immunology and immunotherapy and contribute significantly to further progress in the field. |
| fda approved til therapy: NK Cells in Cancer Immunotherapy: Successes and Challenges Anahid Jewett, Yuman Fong, 2022-12-06 NK Cells in Cancer Immunotherapy: Successes and Challenges explains the latest immunotherapeutic strategies, focusing on NK cells to allow the best and precise combination treatments to cancer patients. The book provides existing background knowledge in the field of immunotherapy and discusses future areas of research required to carry out cutting-edge, validated therapies. Chapters cover advances in immunotherapeutic strategies, in particular, the use of NK cells with and without T-cell therapy in the treatment of cancer. The book is a valuable resource for cancer researchers, oncologists, graduate students and those interested in learning more about novel strategies to treat cancer patients. Immunotherapy is fast becoming the method of choice for cancer therapy. Although remarkable advances have been made in the field of immunotherapy, there are significant challenges and difficulties ahead since many of the current immunotherapeutic strategies do not provide long-lasting treatment strategies, and therefore are not very effective. - Covers CAR/T and CAR/NK and adoptive NK cell therapy with and without T cell therapies - Discusses basic biology of NK cells and mouse models of human cancers and the role of NK cells in metastatic cancer and in cancer stem cells - Encompasses information on combination therapies using check point inhibition, adoptive transfer of cytotoxic effector cells, chemotherapeutic drugs and activating and inhibitory antibodies |
| fda approved til therapy: The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder American Psychiatric Association, 2018-01-11 Alcohol use disorder (AUD) is a major public health problem in the United States. The estimated 12-month and lifetime prevalence values for AUD are 13.9% and 29.1%, respectively, with approximately half of individuals with lifetime AUD having a severe disorder. AUD and its sequelae also account for significant excess mortality and cost the United States more than $200 billion annually. Despite its high prevalence and numerous negative consequences, AUD remains undertreated. In fact, fewer than 1 in 10 individuals in the United States with a 12-month diagnosis of AUD receive any treatment. Nevertheless, effective and evidence-based interventions are available, and treatment is associated with reductions in the risk of relapse and AUD-associated mortality. The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder seeks to reduce these substantial psychosocial and public health consequences of AUD for millions of affected individuals. The guideline focuses specifically on evidence-based pharmacological treatments for AUD in outpatient settings and includes additional information on assessment and treatment planning, which are an integral part of using pharmacotherapy to treat AUD. In addition to reviewing the available evidence on the use of AUD pharmacotherapy, the guideline offers clear, concise, and actionable recommendation statements, each of which is given a rating that reflects the level of confidence that potential benefits of an intervention outweigh potential harms. The guideline provides guidance on implementing these recommendations into clinical practice, with the goal of improving quality of care and treatment outcomes of AUD. |
| fda approved til therapy: Altered Fates Jeff Lyon, 1996 Traces the history of gene therapy research and discusses the politics involved in this medical revolution. |
| fda approved til therapy: Immunotherapy in Resistant Cancer: From the Lab Bench Work to Its Clinical Perspectives Jorge Morales-Montor, Mariana Segovia-Mendoza, 2020-10-02 Immunotherapy in Resistant Cancer: From the Lab Bench Work to Its Clinical Perspectives provides high level knowledge on detailed mechanisms of actions and biological interactions of different immune drugs, with an aim of offering researchers and clinicians cutting-edge therapies to overcome drug resistance. The book explains the latest immunotherapies for different types of cancer, helping users carry out research projects or create alternatives for drug development in the pharmaceutical industry. Topics discussed include the relationship between immunotherapy and macrophages, immune checkpoints in different types of cancer, immune cocktails in solid tumors, and immune-phenotyping. Additionally, the book presents basic and clinical data on immunoresistance and glycosylation. This book is a valuable source for cancer researchers, medical doctors, clinicians and members of the biomedical field who must understand certain mechanisms to fight cancer that is resistant to immunotherapy. |
Lifileucel First Cellular Therapy Approved for Cancer
Mar 5, 2024 · In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses …
TIL Therapy: A New Melanoma Treatment 30 Years in the Making
May 29, 2024 · It All Comes Together: FDA Approves First TIL Therapy In December 2023, researchers reported that almost 50% of patients treated with an investigational TIL therapy …
FDA grants accelerated approval to lifileucel for ...
On February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for...
FDA approves first tumour-infiltrating lymphocyte (TIL ...
Feb 19, 2024 · The US FDA has granted an accelerated approval to Iovance’s lifileucel (Amtagvi) for patients with unresectable or metastatic melanoma. The first-in-modality approval for a...
FDA Approves TIL Therapy for Unresectable or Metastatic …
Feb 16, 2024 · The FDA has granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for the treatment of adults with unresectable or metastatic …
Expert consensus guidelines on management and best practices ...
Based on the encouraging efficacy, tolerable safety profile, and advancements in a central manufacturing process, lifileucel is now the first US Food and Drug Administration (FDA) …
The promise of TIL therapy | Stanford Cancer Institute
In February 2024, the Food and Drug Administration (FDA) greenlit the first cellular therapy to treat solid tumors. Lifileucel (Amtagvi) leverages immune cells called tumor-infiltrating …
Lifileucel First Cellular Therapy Approved for Cancer
Mar 5, 2024 · In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses …
TIL Therapy: A New Melanoma Treatment 30 Years in the Making
May 29, 2024 · It All Comes Together: FDA Approves First TIL Therapy In December 2023, researchers reported that almost 50% of patients treated with an investigational TIL therapy …
FDA grants accelerated approval to lifileucel for ...
On February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell …
FDA approves first tumour-infiltrating lymphocyte (TIL ...
Feb 19, 2024 · The US FDA has granted an accelerated approval to Iovance’s lifileucel (Amtagvi) for patients with unresectable or metastatic melanoma. The first-in-modality approval for a...
FDA Approves TIL Therapy for Unresectable or Metastatic …
Feb 16, 2024 · The FDA has granted accelerated approval to lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, for the treatment of adults with unresectable or metastatic …
Expert consensus guidelines on management and best practices ...
Based on the encouraging efficacy, tolerable safety profile, and advancements in a central manufacturing process, lifileucel is now the first US Food and Drug Administration (FDA) …
The promise of TIL therapy | Stanford Cancer Institute
In February 2024, the Food and Drug Administration (FDA) greenlit the first cellular therapy to treat solid tumors. Lifileucel (Amtagvi) leverages immune cells called tumor-infiltrating …
