Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs

Erin P Balogh; Andrew B Bindman; S Gail Eckhardt; Susan Halabi; R Donald Harvey; Ishmael Jaiyesimi; Rebecca Miksad; Harold L Moses; Sharyl J Nass; Richard L Schilsky; Steven Sun; Josephine M Torrente; Katherine E Warren

doi:10.1634/theoncologist.2019-0698

Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs

Oncologist. 2020 Mar;25(3):e405-e411. doi: 10.1634/theoncologist.2019-0698. Epub 2019 Dec 8.

Authors

Affiliations

¹ Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA.
² University of California, San Francisco, California, USA.
³ University of Texas at Austin's Dell Medical School, Austin, Texas, USA.
⁴ Duke University, Durham, North Carolina, USA.
⁵ Emory University, Atlanta, Georgia, USA.
⁶ Beaumont Hospital, Royal Oak, Michigan, USA.
⁷ Flatiron Health, New York, New York, USA.
⁸ Vanderbilt University, Nashville, Tennessee, USA.
⁹ American Society of Clinical Oncology, Alexandria, Virginia, USA.
¹⁰ Janssen Research and Development, Raritan, New Jersey, USA.
¹¹ Hyman, Phelps & McNamara, P.C., Washington, DC, USA.
¹² Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.

Abstract

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number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling.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.

Keywords: Cancer; Drug approval; Drug legislation; Drug prescriptions; Pharmaceutical research.

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Drug Labeling
Drug Prescriptions
Humans
Neoplasms* / drug therapy
Pharmaceutical Preparations*
Pilot Projects
Vereinigte Staaten
United States Food and Drug Administration

Substances

Pharmaceutical Preparations