Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Executive Summary
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...
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Trial Design Issues, Failure To Follow Guidance Likely to Hurt Merck At Keytruda Advisory Panel
Merck’s decisions to repeatedly ignore US FDA’s advice will be on display as the company tries to convince the agency’s Oncologic Drug’s Advisory Committee the immunotherapy is ready for accelerated approval for patients with high-risk early-stage triple-negative breast cancer based on interim study results.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: