Keytruda And FDA’s Oncology Center of Excellence: The Regulatory Milestones Keep Coming
Merck’s anti-PD-1 therapy Keytruda keeps piling up new indications, including three approved by US FDA in just two weeks – all during a pandemic. The remarkable therapy has been a centerpiece for an equally remarkable period of regulatory innovation.
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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.
Merck’s Keytruda: The ‘Wall Of Data’ Still Holds After ODAC Look Back
Merck has pulled one Accelerated Approval indication for Keytruda already this year, and a second may have to be withdrawn as well. That will leave the product with 27 indications in the US – unless, of course, more are approved before the AA indications are formally pulled.
Woodcock: COVID-19 Pandemic Is Not The Time For Structural Changes At US FDA
Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.