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.