FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs.

Autor:	Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland. paul.kluetz@fda.hhs.gov., Keegan P; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Demetri GD; American Association for Cancer Research, Philadelphia, Pennsylvania.; Dana-Farber Cancer Institute, Boston, Massachusetts., Thornton K; American Association for Cancer Research, Philadelphia, Pennsylvania.; Memorial Sloan Kettering Cancer Center, New York, New York., Sul J; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Kim J; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Katzen H; George Washington School of Medicine, Washington, D.C., Burke LB; LORA Group, LLC, Royal Oak, Maryland., Harvey RD; Emory University School of Medicine, Atlanta, Georgia., Alebachew E; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Agrawal S; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland., Nair A; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland., Donoghue M; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland., Shord SS; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, Maryland., Gao JJ; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Feb 15; Vol. 27 (4), pp. 916-921. Date of Electronic Publication: 2020 Nov 30.
DOI:	10.1158/1078-0432.CCR-20-3213
Abstrakt:	The FDA conducts independent reviews of scientific data obtained with investigational drug products to ensure that they are safe and effective. As a result of this process, FDA-approved product labeling is generated that is considered one of the most trusted sources of information for use of an approved drug. But FDA approval is only the beginning of the life cycle of a new drug; the first oncology drugs now have more than 7 decades of clinical experience in the postmarketing setting. Due, in part, to lack of incentives, some companies may not seek inclusion of new data, other than new safety information, in FDA-approved product labeling. Ensuring that product labeling provides adequate directions for use is important for all drugs, including older therapies that may form the backbone of many standard combination regimens for pediatric and adult cancers. Project Renewal is an FDA Oncology Center of Excellence pilot program that leverages expertise from the clinical and scientific oncology communities to review published literature and generate a drug-specific product report summarizing data that may support updates to FDA-approved product labeling. This article provides a broad overview of Project Renewal's collaborative pilot process for identifying and assessing literature supporting potential labeling updates, while engaging the oncology community to increase awareness of FDA's evidentiary standards and deliberative processes used when considering the addition of new indications and dosing regimens to product labeling. (©2020 American Association for Cancer Research.)
Databáze:	MEDLINE
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