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.
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The company previously was unsuccessful securing accelerated approval based on complete response data, but event-free survival results may be more persuasive.
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.
Final guidance from FDA on accelerated approval pathway based on pathological complete response in neoadjuvant breast cancer clarifies that one large trial is the “default” for most applications.