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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

Agenus Inc.’s recent BLA withdrawal for the PD-1 inhibitor balstilimab in second-line cervical cancer has shined a light on rare instances in which a drug seeking accelerated approval is blocked by a competing product’s conversion from accelerated to regular approval.

However, the Agenus experience offers some lessons for sponsors more broadly by highlighting the regulatory risk that comes with pinning...

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