Agenus (AGEN) Withdraws Balstilimab BLA

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Go back to Agenus (AGEN) Withdraws Balstilimab BLA

Agenus Provides Update on Balstilimab Development

October 22, 2021 8:00 AM EDT

Company voluntarily withdraws BLA at FDAs recommendation following full approval of pembrolizumab, which came four months earlier than FDA goal dateBalstilimab achieved trial endpoints with 20% response rates in PD-L1 positive patients, versus 14% reported in pembrolizumabs label; Agenus successfully completed 3 FDA pre-approval inspections for the PDUFA date of Dec. 16, 2021Agenus plans to launch expanded access programs to give patients access to balstilimab in several countries, including the USAgenus will discontinue its ongoing confirmatory trial (BRAVA) in this population, which is expected to reduce R&D expenses by over $100MAccelerated... More