Accelerated Approval Roadblock: Agenus’ PD-1 Stumble Reflects Pathway’s Regulatory Risk

 
• By Sue Sutter and Bridget Silverman

Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.

Roadblock
Balstilimab's road to accelerated approval was blocked by Keytruda's conversion to regular approval in second-line cervical cancer. • Source: Alamy

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