Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.
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The study, in ER+/HER2- breast cancer, met the pCR co-primary endpoint. Merck previously tried without success to win accelerated approval for Keytruda in TNBC using pCR as a surrogate for EFS.
Keeping Track: GSK Earns New Claims For Shingrix, Nucala; Keytruda’s TNBC Label Grows; CRL For Iterum
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Merck unveiled event-free survival results for Keytruda in triple-negative breast cancer following failure earlier this year to gain approval on a surrogate endpoint.