Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs

被引：2

作者：

Balogh, Erin P. ^{[1
]}

Bindman, Andrew B. ^{[2
]}

Eckhardt, S. Gail ^{[3
]}

Halabi, Susan ^{[4
]}

Harvey, R. Donald ^{[5
]}

Jaiyesimi, Ishmael ^{[6
]}

Miksad, Rebecca ^{[7
]}

Moses, Harold L. ^{[8
]}

Nass, Sharyl J. ^{[1
]}

Schilsky, Richard L. ^{[9
]}

Sun, Steven ^{[10
]}

Torrente, Josephine M. ^{[11
]}

Warren, Katherine E. ^{[12
]}

机构：

[1] Natl Acad Sci Engn & Med, Hlth & Med Div, 500 Fifth St NW, Washington, DC 20001 USA

[2] Univ Calif San Francisco, San Francisco, CA 94143 USA

[3] Univ Texas Austin, Dell Med Sch, Austin, TX 78712 USA

[4] Duke Univ, Durham, NC USA

[5] Emory Univ, Atlanta, GA 30322 USA

[6] Beaumont Hosp, Royal Oak, MI USA

[7] Flatiron Hlth, New York, NY USA

[8] Vanderbilt Univ, 221 Kirkland Hall, Nashville, TN 37235 USA

[9] Amer Soc Clin Oncol, Alexandria, VA USA

[10] Janssen Res & Dev, Raritan, NJ USA

[11] Hyman Phelps & McNamara PC, Washington, DC USA

[12] Dana Farber Boston Childrens Canc & Blood Disorde, Boston, MA USA

来源：

ONCOLOGIST | 2020年 / 25卷 / 03期

关键词：

Cancer; Drug prescriptions; Drug legislation; Drug approval; Pharmaceutical research;

D O I：

10.1634/theoncologist.2019-0698

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

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of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling.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

引用

页码：E405 / E411

页数：7

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