Accelerated Approval’s Double-Edged Sword Cuts Down Agenus’ Balstilimab BLA

 
• By Bridget Silverman

With US FDA’s early conversion of Merck’s Keytruda to full approval for chemotherapy-experienced cervical cancer, Agenus lost its expedited path to market and has opted to focus on development of combination treatments instead.

Russian Naval Dagger. Alamy-CPJP8D
US FDA's accelerated approval pathway offers unique benefits and vulnerabilities for sponsors. • Source: Alamy

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