Roche with­draws Tecen­triq in blad­der can­cer amid FDA's sweep­ing re­view on ac­cel­er­at­ed ap­provals

The “in­dus­try-wide re­view of ac­cel­er­at­ed ap­provals” that’s been mak­ing waves in the check­point field has reached Roche.

With prod­ding from the FDA, the Swiss phar­ma gi­ant says it’s pulling a blad­der can­cer in­di­ca­tion for Tecen­triq in the US — more than three years af­ter it con­ced­ed a stun­ning fail­ure in the orig­i­nal con­fir­ma­to­ry study.

Like his coun­ter­parts at Bris­tol My­ers Squibb, As­traZeneca and Mer­ck, all of which have dis­closed with­drawals in re­cent weeks, Roche R&D chief Levi Gar­raway praised the ac­cel­er­at­ed ap­proval pro­gram and high­light­ed the PD-L1 drug’s ben­e­fits in oth­er can­cer types de­spite the “dis­ap­point­ing” de­ci­sion.

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