STAT+: FDA reviews accelerated approvals as two drug makers withdraw bladder cancer indications

For the second time in less than a month, a drug maker has pulled an indication for a medicine after a follow-up clinical trial failed to meet its primary goal. And the moves come as part of a U.S. regulatory review of so-called accelerated approvals, a controversial strategy that has been used to hasten availability of treatments for serious conditions.

The latest reversal concerns Tecentriq, a Roche (RHHBY) drug that was granted accelerated approval in 2016 to treat bladder cancer. A trial to confirm the benefits subsequently showed it failed to improve overall survival. Last month, AstraZeneca (AZN) withdrew a bladder cancer indication for Imfinzi after a follow-up trial also showed the drug failed to improve overall survival.

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STAT+: FDA reviews accelerated approvals as two drug makers withdraw bladder cancer indications

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