Trial Design Issues, Failure To Follow Guidance Likely to Hurt Merck At Keytruda Advisory Panel

 
• By Sarah Karlin-Smith

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.

Molecular model of Keytruda
FDA is asking an advisory panel whether Merck's Keytruda needs more data before a regulatory decision for triple-negative breast cancer can be made • Source: Shutterstock

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