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Agenus Needs Phase III For BOT/BAL, Another Example Of Shifting Accelerated Approval Climate

 
• By Alaric DeArment

The US FDA surprised some observers when it advised Agenus against filing for accelerated approval of the CTLA-4/PD-1 combination, but the agency has been cracking down on confirmatory trial requirements recently to better ensure the studies will be finished.

The FDA clarified a Phase III and standard submission pathway for BOT/BAL. • Source: Shutterstock

Agenus Inc. got an unwelcome surprise from the US Food and Drug Administration, which recommended against the company filing for accelerated approval for the combination of its CTLA-4-targeting monoclonal antibody botensilimab and the PD-1-targeting balstilimab (BOT/BAL) in relapsed/refractory microsatellite-stable colorectal cancer (MSS CRC) with no active liver metastases.

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