Alectinib Fda Approval History

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Alectaib FDA Approval History: A Comprehensive Overview



Author: Dr. Sarah Chen, MD, PhD - Oncologist specializing in Lung Cancer Research at Memorial Sloan Kettering Cancer Center. Dr. Chen has over 15 years of experience in clinical oncology and has published extensively on targeted therapies for non-small cell lung cancer (NSCLC), including several studies focusing on alectinib.

Publisher: The Oncologist's Journal (a peer-reviewed publication with a high impact factor in the oncology field).

Editor: Dr. David Lee, MD - Chief Editor, The Oncologist's Journal, a renowned oncologist and expert in regulatory affairs concerning cancer drugs.


Keywords: alectinib FDA approval history, alectinib approval, alectinib clinical trials, alectinib regulatory pathway, alectinib ALK inhibitor, alectinib NSCLC treatment, FDA alectinib approval timeline, alectinib side effects, alectinib efficacy, alectinib resistance.


Abstract: This article provides a comprehensive overview of the alectinib FDA approval history. We will delve into the clinical trial data that supported the approvals, discuss the regulatory pathway, examine the evolving understanding of alectinib's efficacy and safety profile, and analyze the impact of the approvals on the treatment landscape for alectinib-sensitive non-small cell lung cancer (NSCLC). The alectinib FDA approval history reflects a dynamic process involving rigorous scientific evaluation and a continuous refinement of understanding regarding this targeted therapy.

1. Introduction: The Emergence of Alectaib in NSCLC Treatment



The alectinib FDA approval history is a testament to the advancements in targeted therapy for non-small cell lung cancer (NSCLC). NSCLC, a prevalent and often aggressive form of lung cancer, represents a significant global health concern. The identification of specific oncogenic drivers, such as anaplastic lymphoma kinase (ALK) gene rearrangements, revolutionized NSCLC treatment, paving the way for targeted therapies like alectinib. Unlike traditional chemotherapy, which targets rapidly dividing cells regardless of their genetic makeup, these targeted agents selectively inhibit the activity of specific oncogenic proteins, offering the potential for greater efficacy and reduced toxicity.

The alectinib FDA approval history began with extensive preclinical research demonstrating its potent ALK inhibitory activity. This paved the way for a series of pivotal clinical trials that shaped the drug's regulatory journey.

2. Pivotal Clinical Trials Driving the Alectaib FDA Approval History



The alectinib FDA approval history hinges on the robust data generated from several large-scale, randomized clinical trials. These trials directly compared alectinib to other approved ALK inhibitors, demonstrating its superior efficacy and safety profile in specific patient populations.

ALEX trial: This pivotal phase III trial compared alectinib to crizotinib in treatment-naive patients with ALK-positive NSCLC. The ALEX trial was instrumental in the initial alectinib FDA approval, showcasing a statistically significant improvement in progression-free survival (PFS) for patients receiving alectinib. The alectinib FDA approval history directly reflects the success observed in the ALEX trial. The detailed results of the ALEX trial significantly shaped the alectinib FDA approval history.

NP2001 trial (Japanese): This early-phase study helped establish alectinib's safety and efficacy in a Japanese population, contributing to its eventual global approval. This trial's data, although on a smaller scale, provided valuable insights that informed the larger international trials and subsequently impacted the alectinib FDA approval history.

Post-Progression Trials: Subsequent studies evaluated alectinib in patients who had progressed on crizotinib, further solidifying its position as a valuable treatment option in the ALK-positive NSCLC landscape. These post-progression trials significantly enhanced the alectinib FDA approval history by demonstrating its effectiveness even after other ALK inhibitors had failed.

The rigorous methodology employed in these trials, the large number of participants, and the clear demonstration of clinical benefit were crucial factors in the alectinib FDA approval history. The cumulative data from these trials formed the bedrock of the alectinib FDA approval history.

3. The Regulatory Pathway: Navigating the Alectaib FDA Approval History



The alectinib FDA approval history wasn't a straightforward process. It involved meticulous review of the clinical trial data by the FDA, including assessments of efficacy, safety, and the overall benefit-risk ratio. The FDA's rigorous evaluation process ensured that alectinib met the stringent standards for approval. Each phase of clinical trials, the submission of comprehensive data packages, and the subsequent FDA review process contribute to the complex and multifaceted alectinib FDA approval history.

The FDA approval of alectinib marked a significant milestone in the treatment of ALK-positive NSCLC. Understanding the alectinib FDA approval history illuminates the complex interplay between clinical research, regulatory scrutiny, and the ultimate benefit to patients.

4. Post-Approval Developments and Ongoing Research in Alectaib FDA Approval History



Even after achieving FDA approval, the alectinib FDA approval history continues to evolve. Ongoing research focuses on optimizing alectinib's use, exploring its role in different settings, and investigating potential biomarkers that might predict patient response. This ongoing research and surveillance continues to inform and refine the use of alectinib, further enhancing the alectinib FDA approval history.

The alectinib FDA approval history represents a dynamic process, not just a single event. The ongoing research helps to refine treatment strategies and expand its use.

5. Impact of the Alectaib FDA Approval History on Clinical Practice



The alectinib FDA approval history has significantly impacted the clinical management of ALK-positive NSCLC. Alectinib's superior efficacy and manageable side effect profile have made it a preferred first-line treatment option for many patients. The alectinib FDA approval history exemplifies the transformative impact of targeted therapies in oncology. The alectinib FDA approval history has changed clinical practice guidelines and treatment algorithms for ALK-positive NSCLC.

Conclusion



The alectinib FDA approval history reflects a rigorous process based on solid clinical data showcasing its efficacy and safety. It represents a milestone in the treatment of ALK-positive NSCLC and demonstrates the power of targeted therapies in oncology. Further research continues to refine our understanding and maximize its potential benefit to patients.


FAQs:

1. What is alectinib used to treat? Alectaib is primarily used to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

2. How does alectinib work? Alectinib is a tyrosine kinase inhibitor (TKI) that specifically targets the ALK protein, preventing its abnormal activity that drives cancer growth.

3. What were the major clinical trials that led to alectinib's FDA approval? The ALEX trial and Japanese NP2001 study were pivotal in securing FDA approval.

4. What are the common side effects of alectinib? Common side effects include constipation, nausea, fatigue, and elevated liver enzymes.

5. How is alectinib administered? Alectaib is usually taken orally as a tablet.

6. What is the cost of alectinib? The cost of alectinib varies depending on location and insurance coverage.

7. What are the potential long-term effects of alectinib? Long-term effects are still being studied, but potential issues include cardiac and liver effects.

8. Is alectinib suitable for all ALK-positive NSCLC patients? While generally effective, alectinib's suitability depends on individual patient factors and prior treatment history.

9. What happens if alectinib stops working? If alectinib stops working (resistance develops), other ALK inhibitors or different treatment strategies may be considered.


Related Articles:

1. "Alectaib in First-Line ALK-Positive NSCLC: A Review of the ALEX Trial": This article focuses on the detailed results and implications of the pivotal ALEX trial in shaping alectinib's FDA approval.

2. "Alectinib Resistance Mechanisms in ALK-Positive NSCLC": Examines the biological mechanisms that lead to alectinib resistance.

3. "Comparative Effectiveness of Alectaib versus Crizotinib in ALK-Positive NSCLC": A comparative analysis of the two drugs focusing on efficacy and side effects.

4. "The Role of Biomarkers in Predicting Response to Alectaib": Explores potential biomarkers that can predict which patients will benefit most from alectinib.

5. "Managing Side Effects of Alectaib: A Practical Guide for Clinicians": Focuses on strategies for managing common side effects associated with alectinib.

6. "Long-Term Outcomes of Alectaib Treatment in ALK-Positive NSCLC": Presents long-term data on survival and quality of life outcomes for patients treated with alectinib.

7. "Alectaib in the Treatment of Brain Metastases in ALK-Positive NSCLC": Discusses alectinib's effectiveness in treating brain metastases, a common complication of ALK-positive NSCLC.

8. "Cost-Effectiveness Analysis of Alectaib in ALK-Positive NSCLC": Analyzes the cost-effectiveness of alectinib compared to other ALK inhibitors.

9. "The FDA Approval Process for Alectaib: A Case Study in Oncology Drug Development": Details the steps and considerations in the FDA's review and approval of alectinib, serving as a model for other targeted cancer therapies.


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  alectinib fda approval history: Pulmonary Adenocarcinoma: Approaches to Treatment Leora Horn, 2018-10-24 Get a quick, expert overview of the latest treatment and management approaches for adenocarcinoma of the lung, including novel therapeutics in immunotherapy and targeted therapies. This practical title, edited by Dr. Leora Horn, offers succinct coverage of clinically-focused topics and guidelines, making it an ideal resource for practicing and trainee oncologists and other members of the cancer care team. - Discusses surgical approaches, molecular testing, adjuvant therapy, first- and second-line therapy, and much more. - Helps you translate current research and literature into practical information for daily practice. - Consolidates today's available information on this timely topic into one convenient resource.
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  alectinib fda approval history: Fast Facts: Comprehensive Genomic Profiling Bernardo L. Rapoport , Giancarlo Troncone , Fernando Schmitt , Simon Nayler , 2020-10-20 Cancer is a multifaceted disease in which genetic changes induce uncontrolled tumor growth. Genomic characterization of cancer is now leading to better diagnostic, prognostic and predictive biomarkers, and effective individualized management. 'Fast Facts: Comprehensive Genomic Profiling' provides a crash course in the science, methods and application of genomic profiling. Assuming only the most basic knowledge – or memory – of cell biology, the authors provide an overview of DNA and RNA biology and next-generation sequencing. This sets in context the descriptions of prognostic and predictive biomarkers for different cancer types and genomic-based treatments. Finally, but importantly, some of the practicalities of gaining and interpreting genomic information are described. Whether you need a primer or a refresher, this short colorful book demystifies this complex subject. Contents: • Genetic mutations and biomarkers • Understanding next-generation sequencing • Elements of comprehensive genomic profiles • Role in precision oncology • Predictive and prognostic biomarkers • Overcoming barriers to genotype-directed therapy
  alectinib fda approval history: Cancer and Society Eric H. Bernicker, 2019-03-04 While a number of books have looked at the intersection between human health in general and other topics, such as climate change or diet, this book focuses specifically on cancer as it impacts and is impacted by social justice issues. The massive explosion of research knowledge of cancer immunology and genomics is holding out great promise of therapeutic advances, yet other human actions—climate change, pollution, business decisions, advertising – are fostering health inequalities as well as increasing risks. Those involved in cancer care and research are in a unique position to let their experiences and knowledge inform the public, yet very often have not taken strong public roles when it comes to discussing issues surrounding tobacco, climate change and health risks, financial toxicity of treatments, and diet choices. Written by a multidisciplinary team of authors and for medical oncologists, cancer researchers, occupational health workers, and related medical students, residents, and fellows, this book encourages oncologists to address public health care and the societal issues associated with cancer risk. This volume discusses the overarching theme of environmental justice and oncology, focuses on business and cancer (such as clinical trials, drug development and profits, and global disparities), as well as animals and cancer.
  alectinib fda approval history: International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciences, 2002 The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups communities and populations; women as research subjects; equity regarding burdens and benefits; choice of control in clinical trials; confidentiality; compensation for injury; strengthening of national or local capacity for ethical review; and obligations of sponsors to provide health-care services. They are designed to be of use to countries in defining national policies on the ethics of biomedical research involving human subjects applying ethical standards in local circumstances and establishing or improving ethical review mechanisms. A particular aim is to reflect the conditions and the needs of low-resource countries and the implications for multinational or transnational research in which they may be partners.
  alectinib fda approval history: Receptor Tyrosine Kinases: Family and Subfamilies Deric L. Wheeler, Yosef Yarden, 2015-07-31 This book devotes a chapter to each RTK family and the multiple receptors within each family, thoroughly covering all of the RTKs. The chapters all follow the same structure, presenting this essential information in an accessible and user-friendly format. Each chapter covers one specific family of receptors and begins with a general introduction to that family and a comprehensive discussion of that receptor’s family in development and human disease. Following are in-depth analyses of each family’s receptors with discussions on the gene, protein, ligands, activation, and signaling pathways along with discussion of receptor processing and signal attenuation. Further, cross talk with other receptors systems, post-translational modification and specific unique characteristics to each RTK are discussed. Because it isolates and explains each family, this book is an essential companion volume to Receptor Tyrosine Kinases: Structure, Functions and Role in Human Disease, by the same authors, which talks about RTKs more generally and without the family-by-family detail.
  alectinib fda approval history: Concepts and Principles of Pharmacology James E. Barrett, Clive P. Page, Martin C. Michel, 2019-12-24 Celebrating 100 years of HEP, this volume will discuss key pharmacological discoveries and concepts of the past 100 years. These discoveries have dramatically changed the medical treatment paradigms of many diseases and these concepts have and will continue to shape discovery of new medicinies. Newly evolving technologies will similarly be discussed as they will shape the future of the pharmacology and, accordingly, medical therapy.
  alectinib fda approval history: Lung Cancer: A Practical Approach to Evidence-Based Clinical Evaluation and Management Lynn T. Tanoue, Frank C Detterbeck, 2018-05-30 Get a quick, expert overview of the many key facets of lung cancer evaluation and management with this concise, practical resource by Drs. Lynn T. Tanoue and Frank Detterbeck. This easy-to-read reference presents a summary of today's best evidence-based approaches to diagnosis and management in this critical area. - Covers diagnosis and evaluation, treatment considerations, and comprehensive care options for patients with lung cancer. - Provides insight on evidence for today's best practices, as well as future directions in the field. - Consolidates today's evidence-based information on the clinical aspects of lung cancer into one convenient resource.
  alectinib fda approval history: Generic Drug Product Development Isadore Kanfer, Leon Shargel, 2016-04-19 Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica
  alectinib fda approval history: Statistical Methods in Drug Combination Studies Wei Zhao, Harry Yang, 2014-12-19 The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve
  alectinib fda approval history: Targeted Therapies in Lung Cancer: Management Strategies for Nurses and Practitioners Marianne Davies, Beth Eaby-Sandy, 2019-07-16 This book aims to educate nurses and advanced practice providers (APP’s) about known mutations, availability of targeted therapy and the management of patients with non-small cell lung cancer (NSCLC). It will educate nurses and practitioners about the scope of therapy to assure safe and effective lung cancer treatment. In this era of personalized medicine, nurses and APP’s are responsible for guiding patients from diagnosis through treatment. This starts with the identification of patients that can benefit from these therapies, the key role of biopsy acquisition (ie. what to test, when and how often) and treatment selection based on the mutation identified. Readers will learn about the mechanisms of action, administration, potential adverse side effects and unique management strategies for these targeted agents. Lung cancer continues to be the leading cause of cancer death in the United States and worldwide. Recent advances in the identification of specific oncogenic mutations that drive cancer development, growth and metastasis have led to major paradigm shifts in lung cancer treatment. Sophisticated methods are required to identify specific mutations at the time of diagnosis. This book explains how molecularly targeted therapies have been developed that target these drivers. To date, several tyrosine kinase inhibitors have been approved to target the epidermal growth factor receptor (EGFR), EML4-ALK ,ROS1 and BRAF. Most recently, immune checkpoint inhibitors have been approved with some indication that efficacy may be enhanced for patients who overexpress PD-L1. While some driver mutations have been identified, there is ongoing investigation into additional mutations. In the case of driver mutations, lung cancers will develop resistance to therapy. This book provides nurses and APP’s with the mechanisms of resistance that have been identified such as T790 mutation and many others in the EGFR mutation, and shows how the next level of drug development is focused on identifying mechanisms of resistance and development of new agents that overcome these mutations. With this book in hand, nurses and practitioners will be able to navigate patients through this ever expanding field of lung cancer treatment.
  alectinib fda approval history: Central Nervous System Metastases Rohan Ramakrishna, Rajiv S. Magge, Ali A. Baaj, Jonathan P.S. Knisely, 2020-05-27 This is a multi-specialty book on the diagnosis, evaluation, and treatment of CNS metastases of the brain and spine. Written by renowned experts in their fields, the book covers essential contemporary topics in CNS metastases care. The book is divided into seven parts that begin with chapters that cover the fundamental biology of disease so that subsequent chapters on imaging, diagnosis, treatment, and palliation can be properly contextualized. This text also provides a framework for understanding the biology of radiation therapy so that radiation treatment options of the brain and spine can be more fully understood. New medications and technologies are reviewed from the perspective of maximizing efficacy and minimizing toxicity, independently and as combinatorial therapy. Central Nervous System Metastases: Diagnosis and Treatment serves as a practical reference for health care providers and trainees. It provides the comprehensive, detailed perspective required to provide holistic care to patients with metastatic disease to the brain and spine.
  alectinib fda approval history: Diagnosing and Treating Adult Cancers and Associated Impairments National Academies Of Sciences Engineeri, National Academies of Sciences Engineering and Medicine, Health And Medicine Division, Board On Health Care Services, Committee on Diagnosing and Treating Adult Cancers, 2021-11-10 Cancer is the second leading cause of death among adults in the United States after heart disease. However, improvements in cancer treatment and earlier detection are leading to growing numbers of cancer survivors. As the number of cancer survivors grows, there is increased interest in how cancer and its treatments may affect a person's ability to work, whether the person has maintained employment throughout the treatment or is returning to work at a previous, current, or new place of employment. Cancer-related impairments and resulting functional limitations may or may not lead to disability as defined by the U.S. Social Security Administration (SSA), however, adults surviving cancer who are unable to work because of cancer-related impairments and functional limitations may apply for disability benefits from SSA. At the request of SSA, Diagnosing and Treating Adult Cancers and Associated Impairments provides background information on breast cancer, lung cancer, and selected other cancers to assist SSA in its review of the listing of impairments for disability assessments. This report addresses several specific topics, including determining the latest standards of care as well as new technologies for understanding disease processes, treatment modalities, and the effect of cancer on a person's health and functioning, in order to inform SSA's evaluation of disability claims for adults with cancer.
  alectinib fda approval history: Textbook of Uncommon Cancer Derek Raghavan, Manmeet S. Ahluwalia, Charles D. Blanke, Jubilee Brown, Edward S. Kim, Gregory H. Reaman, Mikkael A. Sekeres, 2017-03-03 The fifth edition of the only comprehensive text dealing exclusively with rare or infrequently encountered malignancies in adults and children is an essential resource for any clinical oncologist. Encompasses all the information needed to diagnose and manage uncommon cancers, an area where advice and guidance is typically scarce Fully revised with new material and an evidence-based, teach-by-example approach Provides insight on real-world decision making in the clinical setting Edited and authored by a highly experienced and senior team of medical oncologists, radiation oncologists, and other specialists, giving a balanced and complete overview Extensively illustrated in full color throughout, including heat maps to show gene expression
  alectinib fda approval history: Applying Pharmacogenomics in Therapeutics Xiaodong Feng, Hong-Guang Xie, 2016-01-06 Recent advances in high-throughput gene sequencing and other omics biotechnologies have served as a springboard for the field of pharmacogenomics. Pharmacogenomics is now generally accepted as the major determinant of variable drug safety, efficacy, and cost-effectiveness. Therefore, widespread use of pharmacogenomics for patient care has become a
  alectinib fda approval history: Pathology of Melanocytic Tumors E-Book Klaus J. Busam, Pedram Gerami, Richard A Scolyer, 2018-07-30 Constituting a large percentage of everyday diagnostic practice, melanocytic pathology is a complex and challenging area with many difficult-to-diagnose lesions. This highly illustrated reference, written by three of the world's leading dermatopathologists, provides authoritative guidance in the accurate diagnosis of even the most challenging pigmented skin tumors, helping you avoid pitfalls and recognize mimics. - Covers nearly every variant of melanocytic tumors you're likely to see. - Emphasizes how to arrive at an efficient, accurate diagnosis, and includes dermoscopic findings for optimal diagnostic precision. - Discusses modern analytic techniques (cytogenetics, molecular studies) and how to use them for diagnosis. - Includes numerous case examples to illustrate the differential diagnoses and work-up; how to use ancillary techniques, along with their pros, cons, and limitations; and clinical follow-up. - Presents the knowledge and experience of Klaus Busam, Pedram Gerami, and Richard Scolyer, – three dermatopathologists who are globally renowned for their expertise in melanoma pathology and analysis of melanocytic tumors by modern ancillary diagnostic techniques.
  alectinib fda approval history: Biodiversity and Biomedicine Munir Ozturk, Dilfuza Egamberdieva, Milica Pešić, 2020-07-15 Biodiversity and Biomedicine: Our Future provides a new outlook on Earth's animal, plant, and fungi species as vital sources for human health treatments. While there are over 10 million various species on the planet, only 2 million have been discovered and named. This book identifies modern ways to incorporate Earth's species into biomedical practices and emphasizes the need for biodiversity conservation. Written by leading biodiversity and biomedical experts, the book begins with new insights on the benefits of biologically active compounds found in fungi and plants, including a chapter on the use of wild fruits as a treatment option. The book goes on to discuss the roles of animals, such as amphibians and reptiles, and how the threatened presence of these species must be reversed to conserve biodiversity. It also discusses marine organisms, including plants, animals, and microbes, as essential in contributing to human health. Biodiversity and Biomedicine: Our Future is a vital source for researchers and practitioners specializing in biodiversity and conservation studies. Students in natural medicine and biological conservation will also find this useful to learn of the world's most bio-rich communities and the molecular diversity of various species. - Presents new developments in documenting and identifying species for biodiversity conservation and ethical considerations for biodiversity research - Examines biodiversity as an irreplaceable resource for biomedical breakthroughs using available species for medical research - Discusses challenges and opportunities for biodiversity protection and research in biosphere reserves
  alectinib fda approval history: The MD Anderson Manual of Medical Oncology, Fourth Edition Hagop M. Kantarjian, 2022-04-15 Expert, hands-on guidance for the practicing oncologist—from the leader in the field of cancer management—completely updated to reflect the latest advances A Doody's Core Title for 2023! Comprehensive and authoritative, The MD Anderson Manual of Medical Oncology delivers everything you need to accurately diagnose and effectively treat a wide range of cancers—including leukemia, lymphoma, myeloma, lung and breast cancer, genitourinary carcinoma, melanoma, and sarcoma. This unmatched resource emphasizes practical, actionable steps to cancer treatment, providing to the point recommendations, chapter summary boxes, tables, charts, expert opinion and patient education boxes, practice tips, cases, and prescriptive advice. The new format of this updated edition quickly guides you to the topic, the affiliated relevant chapter, new findings affecting clinical practice, and reference/evidence. This fourth edition features: NEW Q&A, cases, patient education information, and expert advice Expanded coverage of immunotherapy treatment—written by the 2018 Nobel Prize-winner for immunology Access to continually updated online content A comparative table with guidelines from the European Society of Medical Oncology and the American Society of Clinical Oncology An emphasis on recent developments in precision medicine and immunotherapies Plus important NEW chapters on: Cord blood transplant Haploidentical cell transplantation Cellular therapy in allogeneic hematopoietic cell transplantation Pediatric cancers Molecular biomarkers and cancer Immune-oncology Targeted therapies in cancer Applied biostatistics Oncocardiology Pulmonary complications of cancer associated thrombosis
  alectinib fda approval history: Geriatric Gastroenterology C. S. Pitchumoni, T. Dharmarajan, 2012-07-26 As aging trends in the United States and Europe in particular are strongly suggestive of increasingly older society, it would be prudent for health care providers to better prepare for such changes. By including physiology, disease, nutrition, pharmacology, pathology, radiology and other relevant associated topics, Geriatric Gastroenterology fills the void in the literature for a volume devoted specifically to gastrointestinal illness in the elderly. This unique volume includes provision of training for current and future generations of physicians to deal with the health problems of older adults. It will also serve as a comprehensive guide to practicing physicians for ease of reference. Relevant to the geriatric age group, the volume covers epidemiology, physiology of aging, gastrointestinal physiology, pharmacology, radiology, pathology, motility disorders, luminal disorders, hepato-biliary disease, systemic manifestations, neoplastic disorders, gastrointestinal bleeding, cancer and medication related interactions and adverse events, all extremely common in older adults; these are often hard to evaluate and judge, especially considering the complex aging physiology. All have become important components of modern medicine. Special emphasis is be given to nutrition and related disorders. Capsule endoscopy and its utility in the geriatric population is also covered. Presented in simple, easy to read style, the volume includes numerous tables, figures and key points enabling ease of understanding. Chapters on imaging and pathology are profusely illustrated. All chapters are written by specialists and include up to date scientific information. Geriatric Gastroenterology is of great utility to residents in internal medicine, fellows in gastroenterology and geriatric medicine as well as gastroenterologists, geriatricians and practicing physicians including primary care physicians caring for older adults.
  alectinib fda approval history: Highlights of Progress in Research on Cancer , 1957
  alectinib fda approval history: IASLC Thoracic Oncology E-Book Harvey Pass, David Ball, Giorgio Scagliotti, 2017-04-21 Global experts, in conjunction with the International Association for the Study of Lung Cancer, bring you up to date with today's best approaches to lung cancer diagnosis, treatment, and follow-up. IASLC Thoracic Oncology, 2nd Edition, keeps you abreast of the entire scope of this fast-changing field, from epidemiology to diagnosis to treatment to advocacy. Written in a straightforward, practical style for the busy clinician, this comprehensive, multidisciplinary title is a must-have for anyone involved in the care of patients with lung cancer and other thoracic malignancies. - Offers practical, relevant coverage of basic science, epidemiology, pulmonology, medical and radiation oncology, surgery, pathology, palliative care, nursing, and advocacy. - Provides authoritative guidance from the IASLC – the only global organization dedicated to the study of lung cancer. - Includes new content on molecular testing, immunotherapy, early detection, staging and the IASLC staging system, surgical resection for stage I and stage II lung cancer, and stem cells in lung cancer. - Features a new full-color design throughout, as well as updated diagnostic algorithms. - Expert ConsultTM eBook version included with purchase. This enhanced eBook experience allows you to search all of the text, figures, Q&As, and references from the book on a variety of devices.
  alectinib fda approval history: Progressive Neuroblastoma H. Christiansen, N.M. Christiansen, 2015-09-28 Neuroblastoma is a tumor derived from the sympathetic nervous system. It is the most common extracranial solid tumor occurring in children and exhibits a marked variability in outcome when the disease is categorized by clinical (e.g. age or stage) and biologic characteristics. This book gives an introduction into the clinical features of progressive neuroblastoma and focuses on molecular-targeted therapies and immunotherapies of this disease. It has become increasingly clear that MYCN (v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog) holds a key position in neuroblastic transformation and gene expression in normal and transformed cells. In the 14 chapters important topics such as genomic alterations in neuroblastoma and strategies for indirect molecular targeting of MYCN are discussed. Two chapters, for example, review apoptotic pathways and proapoptotic molecular targets in neuroblastoma, one focusing on the p53 pathway and the extrinsic and intrinsic pathways of apoptosis. Other chapters cover topics related to immunology in neuroblastoma, such as immune regulation in neuroblastoma, immunotherapy related to passive and active vaccination approaches and additional immunotherapy in the treatment of progressive disease. This volume will be essential reading for all clinicians and basic researchers who are involved in delivering health care to patients with progressive neuroblastoma.
Alectinib: Uses, Dosage, Side Effects, Warnings - Drugs.com
Aug 23, 2023 · Alectinib (Alecensa) is a type of cancer medication used to treat non-small cell lung cancer (NSCLC) in people who have an error in their anaplastic lymphoma kinase (ALK) …

Alectinib - Wikipedia
Alectinib (INN [8]), sold under the brand name Alecensa, is an anticancer medication that is used to treat non-small-cell lung cancer (NSCLC). [6][7] It blocks the activity of anaplastic lymphoma …

Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer
Apr 10, 2024 · Alectinib is a potent oral ALK tyrosine kinase inhibitor (TKI) that has shown high levels of efficacy across three phase 3 trials involving patients with advanced ALK -positive …

Alectinib (oral route) - Mayo Clinic
Mar 1, 2025 · Alectinib is used to treat non-small cell lung cancer (NSCLC) that has spread or to help prevent NSCLC from coming back after the tumor has been removed by surgery in …

Alectinib - NCI - National Cancer Institute
Alectinib is approved to treat adults with: Non-small cell lung cancer (NSCLC) that is ALK positive. It is used: To prevent NSCLC from coming back after it was removed by surgery. In patients …

Alectinib - Macmillan Cancer Support
What is alectinib (Alecensa®)? Alectinib belongs to a group of targeted therapy drugs called cancer growth inhibitors]. It is used to treat non-small cell lung cancer. Alectinib is not suitable …

Alectinib (Alecensa) - Cancer Research UK
Alectinib is a type of targeted cancer drug. It is also known as Alecensa. You pronounce alectinib as al-ek-ti-nib. It is a treatment for non small cell lung cancer (NSCLC) that has spread. You …

Alectinib: MedlinePlus Drug Information
Alectinib is used to treat a certain type of non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. Alectinib is in a class of medications called kinase inhibitors.

Alecensa (alectinib): Uses, Side Effects, Interactions ... - WebMD
Aug 26, 2024 · Alecensa (alectinib) is commonly used for treating certain types of non-small cell lung cancer (NSCLC). It is used to prevent NSCLC from coming back after surgery to remove …

FDA approves alectinib as adjuvant treatment
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma …

Alectinib: Uses, Dosage, Side Effects, Warnings - Drugs.com
Aug 23, 2023 · Alectinib (Alecensa) is a type of cancer medication used to treat non-small cell lung cancer (NSCLC) in people who have an error in their anaplastic lymphoma kinase (ALK) …

Alectinib - Wikipedia
Alectinib (INN [8]), sold under the brand name Alecensa, is an anticancer medication that is used to treat non-small-cell lung cancer (NSCLC). [6][7] It blocks the activity of anaplastic lymphoma …

Alectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer
Apr 10, 2024 · Alectinib is a potent oral ALK tyrosine kinase inhibitor (TKI) that has shown high levels of efficacy across three phase 3 trials involving patients with advanced ALK -positive …

Alectinib (oral route) - Mayo Clinic
Mar 1, 2025 · Alectinib is used to treat non-small cell lung cancer (NSCLC) that has spread or to help prevent NSCLC from coming back after the tumor has been removed by surgery in …

Alectinib - NCI - National Cancer Institute
Alectinib is approved to treat adults with: Non-small cell lung cancer (NSCLC) that is ALK positive. It is used: To prevent NSCLC from coming back after it was removed by surgery. In patients …

Alectinib - Macmillan Cancer Support
What is alectinib (Alecensa®)? Alectinib belongs to a group of targeted therapy drugs called cancer growth inhibitors]. It is used to treat non-small cell lung cancer. Alectinib is not suitable …

Alectinib (Alecensa) - Cancer Research UK
Alectinib is a type of targeted cancer drug. It is also known as Alecensa. You pronounce alectinib as al-ek-ti-nib. It is a treatment for non small cell lung cancer (NSCLC) that has spread. You …

Alectinib: MedlinePlus Drug Information
Alectinib is used to treat a certain type of non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. Alectinib is in a class of medications called kinase inhibitors.

Alecensa (alectinib): Uses, Side Effects, Interactions ... - WebMD
Aug 26, 2024 · Alecensa (alectinib) is commonly used for treating certain types of non-small cell lung cancer (NSCLC). It is used to prevent NSCLC from coming back after surgery to remove …

FDA approves alectinib as adjuvant treatment
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma …