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.
The biotech company said 18 July that it had an end-of-Phase-II meeting with the FDA and presented data from the Phase II study that was consistent with a Phase I...
Key Takeaways
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Agenus said that during an end-of-Phase-II meeting, the FDA recommended against filing for accelerated approval of BOT/BAL in a type of colorectal cancer based on Phase...
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