Richard Pazdur (via AACR)

FDA pan­el ad­mon­ish­es Mer­ck with a gen­tle — and rare — slap­down for rush­ing its pitch on an ac­cel­er­at­ed OK for ad­ju­vant Keytru­da in TNBC

Mer­ck is go­ing to have to wait longer be­fore the FDA con­sid­ers open­ing the door to us­ing Keytru­da as an ad­ju­vant ther­a­py for high risk, ear­ly-stage triple-neg­a­tive breast can­cer.

Un­der the care­ful guid­ance of FDA can­cer czar Richard Paz­dur, the agency’s ex­pert pan­el on ODAC unan­i­mous­ly turned thumbs down on an ac­cel­er­at­ed ap­proval for Mer­ck’s I-O su­per­star, mark­ing a rare snub for the phar­ma gi­ant that was clear­ly sig­naled well in ad­vance of the ses­sion Tues­day. All 10 pan­elists agreed with the FDA’s as­sess­ment that Mer­ck should wait for more de­fin­i­tive da­ta from KEYNOTE-522.

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