Faster Cancer Drug Approvals Tied to Clinical Benefits

Medscape March 26, 2025
Edited by Katie Lennon

TOPLINE:

Cancer drugs with higher clinical benefit in pivotal trials and without major safety concerns achieve full US Food and Drug Administration (FDA) approval more quickly. Drugs demonstrating substantial benefits in confirmatory trials, including overall survival improvements, convert from accelerated to full approval in median 2.15 years vs 3.70 years for those without such benefits.

METHODOLOGY:

• The accelerated approval program was created in 1992 to expedite FDA drug approval for life-threatening conditions based on surrogate measures deemed reasonably likely to predict clinical benefit. The program has facilitated market access approximately 3 years earlier than traditional approval, though delays in completing confirmatory studies have raised concerns about exposing patients to clinical and financial risks. Recent legislation through the Consolidated Appropriations...

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