Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment
Title Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment PDF eBook
Author National Academies of Sciences, Engineering, and Medicine
Publisher National Academies Press
Total Pages 135
Release 2016-11-10
Genre Medical
ISBN 0309442354

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Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors
Title Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors PDF eBook
Author National Academies of Sciences, Engineering, and Medicine
Publisher National Academies Press
Total Pages 89
Release 2019-10-05
Genre Medical
ISBN 0309490863

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In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these "checkpoint" proteins and thwart the immune system's ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response. To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16â€"17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.

The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology
Title The Drug Development Paradigm in Oncology PDF eBook
Author National Academies of Sciences, Engineering, and Medicine
Publisher National Academies Press
Total Pages 145
Release 2018-02-12
Genre Medical
ISBN 0309457971

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Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Cancer Immunotherapy Principles and Practice

Cancer Immunotherapy Principles and Practice
Title Cancer Immunotherapy Principles and Practice PDF eBook
Author Lisa H. Butterfield, PhD
Publisher Springer Publishing Company
Total Pages 920
Release 2017-06-28
Genre Medical
ISBN 1617052736

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Cancer Immunotherapy Principles and Practice, from the Society of Immunotherapy of Cancer (SITC), is the authoritative reference on cancer immunobiology and the immunotherapy treatments that harness the immune system to combat malignant disease. Featuring five sections and over 50 chapters covering the Basic Principles of Tumor Immunology, Cancer Immunotherapy Targets and Classes, Immune Function in Cancer Patients, Disease Specific Treatments and Outcomes, and Regulatory Aspects of Cancer Immunotherapy, this book covers all major topics that have shaped the development of immunotherapy and propelled it to its current place at the forefront of cancer treatment innovation. This volume is a comprehensive resource for oncologists and fellows, immunologists, cancer researchers, and related practitioners seeking understanding of the basic science and clinical applications of cancer immunotherapy. As well as presenting the evidence for immune-based cancer treatment, it positions immunotherapy in the context of other available cancer treatments and provides data on response rates, risks, and toxicities across a variety of diseases. Filled with detailed tables, and instructive illustrations, as well as key points for quick reference, Cancer Immunotherapy Principles and Practice simplifies a challenging and dynamic subject. Key Features: Clearly summarizes the basic principles and research supporting cancer immunotherapy clinical translation Contains expert guidance and treatment strategies for all immunotherapy classes and agents, including cell-based therapies, monoclonal antibodies, cytokine therapies, checkpoint inhibitors, oncolytic viruses, adjuvant approaches, and treatment combinations Includes expert perspectives from leading authorities in the field Provides information on all FDA-approved immunotherapies, including clinical management and outcome data Discusses clinical aspects of immunotherapy for individual cancer types, including melanoma and other skin cancers, lung cancers, gynecologic cancers, gastrointestinal cancers, hematologic cancers, genitourinary cancers, head and neck cancers, sarcomas, brain and other CNS cancers, breast cancer, and pediatric malignancies. Explains regulatory aspects behind the development and approval of immunotherapy drugs Includes Online Access to the Digital Book

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment

Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment
Title Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment PDF eBook
Author National Academies of Sciences, Engineering, and Medicine
Publisher National Academies Press
Total Pages 135
Release 2016-12-10
Genre Medical
ISBN 030944232X

Download Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment Book in PDF, Epub and Kindle

Immunotherapy is a form of cancer therapy that harnesses the body's immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes. With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

Immunotherapy of Hepatocellular Carcinoma

Immunotherapy of Hepatocellular Carcinoma
Title Immunotherapy of Hepatocellular Carcinoma PDF eBook
Author Tim F. Greten
Publisher Springer
Total Pages 167
Release 2017-10-04
Genre Medical
ISBN 3319649582

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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.

Immunotherapy in Translational Cancer Research

Immunotherapy in Translational Cancer Research
Title Immunotherapy in Translational Cancer Research PDF eBook
Author Laurence J. N. Cooper
Publisher
Total Pages
Release 2018
Genre HEALTH & FITNESS
ISBN 9781118684535

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"Immunotherapy in Translational Cancer Research is a volume in Translational Oncology, an exciting book series that focuses on translational cancer research. Immunotherapy has become a key aspect in the treatment of a wide variety of cancers, and this book is specifically designed for physicians, clinical fellows, medical students, graduate students, scientists, pharmaceutical executives, public health and public policy government leaders and community oncologists. Each chapter is consistently organized and features three essential themes: Development of the immunotherapy; Hurdles that were overcome to scale up and undertake clinical trials; and Clinical experience and application of research. Concepts, examples and alternative strategies to achieve individualized targeted therapy are presented, with thorough consideration of the relevant history, current state and future directions of emerging cancer-fighting therapies, drug development, clinical trials, and governmental resources and regulatory issues."--Provided by publisher.