FDA busts Merck's Keytruda in triple-negative breast cancer with a CRL — not unexpected given its disastrous adcomm
Merck and the FDA have engaged in a high-noon standoff over checkpoint inhibitor Keytruda in triple-negative breast cancer after the agency roundly panned its results in high-risk patients. Now, with a decisive adcomm supporting its criticisms, the FDA has shown Keytruda the door in that indication.
The FDA slapped Keytruda with a CRL in high-risk triple-negative breast cancer after the agency’s Oncologic Drugs Advisory Committee handed out a rather gentle slapdown on the I/O drug’s application last month, Merck said Monday.
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