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.
You may also be interested in...
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
Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint
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.
Keytruda To Enjoy First-To-Market Advantage As TNBC Approval Now More Likely
Merck & Co. unveiled event-free survival data for Keytruda in triple-negative breast cancer, following a failure earlier this year to gain approval on a surrogate endpoint.