FDA blasts Merck's bid for adjuvant Keytruda in TNBC before adcomm, calling late-stage data 'questionable'
Merck’s Keytruda has had few obstacles in its way on the path to dominating the I-O field, which has made the New Jersey drugmaker mostly unafraid to tackle big clinical challenges. But in its bid to take on late-stage triple-negative breast cancer, Keytruda hit a roadblock — and the FDA doesn’t seem excited about its chances at an approval.
The FDA cut down data from Merck’s Phase III KEYNOTE-522 study the drugmaker will take before an advisory committee Monday, highlighting the trial’s immature survival data and complete response results the agency called “of questionable clinical meaningfulness.”
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 102,000+ biopharma pros reading Endpoints daily — and it's free.