Trends in time to withdrawal and full approval of accelerated approval cancer drug indications (1992–2024)

Jenei, Kristina, Hahn, Georg, Kesselheim, Aaron S. and Tibau, Ariadna (2025) Trends in time to withdrawal and full approval of accelerated approval cancer drug indications (1992–2024). Journal of Cancer Policy, 45. ISSN 2213-5383

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Abstract

The US Food and Drug Administration (FDA) accelerated approval program facilitates earlier access to therapies for serious illnesses based on surrogate endpoints reasonably likely to predict clinical benefit. To minimize risk, sponsors are required to conduct post marketing studies to confirm the benefit. Over the past decade, concerns have emerged about the pace and quality of post marketing evidence generation. We analyzed regulatory outcomes of oncology indications granted accelerated approval between 1992 and 2024, using publicly available FDA data. Median time to conversion to regular approval decreased from 4.3 to 2.3 years and time to withdrawal decreased from 9.5 to 3.2 years between the 1992–2013 and 2014–2024 periods (both p

Item Type:	Article
Additional Information:	© 2025 Elsevier Ltd.
Divisions:	Health Policy
Subjects:	R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Date Deposited:	11 Jun 2025 15:09
Last Modified:	17 Jun 2025 14:36
URI:	http://eprints.lse.ac.uk/id/eprint/128360

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