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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