Accelerated Approval Roadblock: Agenus’ PD-1 Stumble Reflects Pathway’s Regulatory Risk
Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.
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Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.
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.
239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval
Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.