Mer­ck KGaA, Pfiz­er's Baven­cio set to seal blad­der can­cer ap­proval af­ter con­fir­ma­to­ry tri­al scores

Baven­cio could use the win.

More than two years af­ter its mak­ers — Ger­many’s Mer­ck KGaA and Pfiz­er — se­cured FDA ap­proval for a form of blad­der can­cer, the com­pa­nies un­veiled that the con­fir­ma­to­ry study test­ing the PD-L1 in­hibitor had per­formed as ex­pect­ed, help­ing pa­tients live longer as a main­te­nance treat­ment ver­sus stan­dard-of-care.

The drug was grant­ed ac­cel­er­at­ed ap­proval on the ba­sis of tu­mor re­sponse and du­ra­tion of re­sponse in May 2017 in pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma (UC) whose dis­ease has pro­gressed dur­ing or af­ter plat­inum-con­tain­ing chemother­a­py. On Mon­day, the com­pa­nies said that da­ta from the con­fir­ma­to­ry JAVELIN Blad­der 100 tri­al showed pa­tients treat­ed with Baven­cio lived sig­nif­i­cant­ly longer than those who re­ceived stan­dard care.

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