Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs

The oncologist

article

Erin P. Balogh¹  Richard L. Schilsky²  Steven Sun³  Josephine M. Torrente⁴  Katherine E. Warren⁵  Andrew B. Bindman⁶  S. Gail Eckhardt⁷  Susan Halabi⁸  R. Donald Harvey⁹  Ishmael Jaiyesimi^1,10  Rebecca Miksad^1,11  Harold L. Moses^1,12  Sharyl J. Nass¹ 

[1] Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine;American Society of Clinical Oncology;Janssen Research and Development;Hyman, Phelps & McNamara, P.C.;Dana-Farber/Boston Children's Cancer and Blood Disorders Center;University of California;University of Texas at Austin's Dell Medical School;Duke University;Emory University;Beaumont Hospital, Royal Oak;Flatiron Health;Vanderbilt University

关键词: Cancer;    Drug prescriptions;    Drug legislation;    Drug approval;    Pharmaceutical research;   

DOI  :  10.1634/theoncologist.2019-0698

学科分类：地质学

来源: AlphaMed Press Incorporated

【 摘 要 】

A number of important drugs used to treat cancer—many of which serve as the backbone of modern chemotherapy regimens—have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.

【 授权许可】

CC BY|CC BY-NC