Up­dat­ed: Roche pulls PD-L1 block­buster's ac­cel­er­at­ed ap­proval in blad­der can­cer

The FDA’s cleanup on aisle ac­cel­er­at­ed ap­proval con­tin­ued this morn­ing as Roche an­nounced it would vol­un­tar­i­ly pull from the mar­ket an in­di­ca­tion for its block­buster can­cer im­munother­a­py Tecen­triq for adult pa­tients with cer­tain types of blad­der or uri­nary tract can­cer.

Roche unit Genen­tech said it made this de­ci­sion fol­low­ing a failed con­fir­ma­to­ry tri­al, and in ac­cor­dance with the re­quire­ments of the FDA’s ac­cel­er­at­ed ap­proval pro­gram, which has been in re­vamp mode, par­tic­u­lar­ly in on­col­o­gy, where many ac­cel­er­at­ed ap­provals have been grant­ed in re­cent years.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA