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Agenus PD-1 Down But Not Out With Cervical Cancer BLA Withdrawal

 
• By Alaric DeArment

The company announced it would withdraw the BLA for balstilimab monotherapy in cervical cancer following Keytruda’s full approval, but it plans to keep developing the drug.

Digital illustration of Cancer cell in colour background
Agenus said it would withdraw the BLA for its PD-1 inhibitor, balstilimab, in 2L cervical cancer • Source: Shutterstock

The full approval of Merck & Co., Inc.’s PD-1 inhibitor Keytruda (pembrolizumab) in cervical cancer months ahead of its target action date has led Agenus Inc. to pull the approval application for its own PD-1 inhibitor, balstilimab, in second-line disease. But while it marks a significant setback for the company, its overall development program for the drug will continue.

Agenus said on 22 October that it made a strategic decision to withdraw the biologic license application for balstilimab as a single agent after the US Food and Drug Administration...

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