FDA panel admonishes Merck with a gentle — and rare — slapdown for rushing its pitch on an accelerated OK for adjuvant Keytruda in TNBC
Merck is going to have to wait longer before the FDA considers opening the door to using Keytruda as an adjuvant therapy for high risk, early-stage triple-negative breast cancer.
Under the careful guidance of FDA cancer czar Richard Pazdur, the agency’s expert panel on ODAC unanimously turned thumbs down on an accelerated approval for Merck’s I-O superstar, marking a rare snub for the pharma giant that was clearly signaled well in advance of the session Tuesday. All 10 panelists agreed with the FDA’s assessment that Merck should wait for more definitive data from KEYNOTE-522.
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