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.”
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