FDA blasts Mer­ck­'s bid for ad­ju­vant Keytru­da in TNBC be­fore ad­comm, call­ing late-stage da­ta 'ques­tion­able'

Mer­ck’s Keytru­da has had few ob­sta­cles in its way on the path to dom­i­nat­ing the I-O field, which has made the New Jer­sey drug­mak­er most­ly un­afraid to tack­le big clin­i­cal chal­lenges. But in its bid to take on late-stage triple-neg­a­tive breast can­cer, Keytru­da hit a road­block — and the FDA doesn’t seem ex­cit­ed about its chances at an ap­proval.

The FDA cut down da­ta from Mer­ck’s Phase III KEYNOTE-522 study the drug­mak­er will take be­fore an ad­vi­so­ry com­mit­tee Mon­day, high­light­ing the tri­al’s im­ma­ture sur­vival da­ta and com­plete re­sponse re­sults the agency called “of ques­tion­able clin­i­cal mean­ing­ful­ness.”

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