FDA ex­tends full ap­proval for Mer­ck­'s Keytru­da in 1st-line blad­der can­cer af­ter mixed ad­comm vote

Mer­ck’s ac­cel­er­at­ed ap­proval for Keytru­da in first-line blad­der can­cer was one of a slate of ear­ly nods put un­der the mi­cro­scope by an FDA ad­vi­so­ry com­mit­tee ear­li­er this year af­ter flop­ping con­fir­ma­to­ry tests. Keytru­da passed that test, and now the FDA is mak­ing its ac­cel­er­at­ed OK of­fi­cial.

The FDA on Tues­day gave its full ap­proval to Keytru­da as a treat­ment for first-line ad­vanced blad­der can­cer pa­tients who are not el­i­gi­ble for plat­inum-based chemo de­spite a con­fir­ma­to­ry out­comes tri­al in an ex­pand­ed pa­tient pop­u­la­tion turn­ing up a dud, Mer­ck said in a state­ment.

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