✅   FDA blocks Agenus' accelerated approval plans for CTLA-4/PD-1 combo

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Agenus is shelving immediate plans for a confirmatory Phase 3 study for its lead immunotherapy program after the FDA “discouraged” it from filing for accelerated approval and asked for a “definitive survival study,” the company said Thursday morning. The biotech’s executives called the feedback from the FDA “disappointing” given that its program — which combines a CTLA-4 antibody with a PD-1 antibody — has shown promise in a cancer type that’s proven particularly challenging and where essentially “nothing works,” they said. While Agenus will keep trying to persuade the FDA to reconsider as it collects more Phase 2 data, it is also talking to European regulators and focusing on other cancer types that could lead to accelerated ...

Endpoints     Jul 18, 2024