Roche pulls dan­gling ac­cel­er­at­ed ap­proval for Tecen­triq in triple-neg­a­tive breast can­cer

Roche on Fri­day de­cid­ed to vol­un­tar­i­ly pull an in­di­ca­tion won via the FDA’s ac­cel­er­at­ed ap­proval path­way for its block­buster PD-L1 drug Tecen­triq.

This is the third ac­cel­er­at­ed ap­proval to be pulled fol­low­ing an ODAC meet­ing last April to re­view six in­di­ca­tions from Roche, Mer­ck and Bris­tol My­ers Squibb block­buster can­cer drugs, where con­fir­ma­to­ry tri­als failed. This is al­so the fourth ac­cel­er­at­ed ap­proval to be pulled in the last month.

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