FDA blasts Merck’s Keytruda data for new breast cancer indication

Stat News, February 5, 2021. The cancer drug Keytruda is a medical and financial juggernaut, but it may not win FDA approval for early-stage triple negative breast cancer. FDA medical reviewers agreed there is a need for new treatments, but Keytruda did not impress them with its small benefit of “questionable clinical meaningfulness” and serious safety issues. NCHR’s Dr. Zuckerman said “This is one of the most negative reviews I’ve ever seen.”

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