For the second time in less than a month, a drug maker has pulled an indication for a medicine after a stick to-up scientific trial failed to meet its major objective. And the moves come as aspect of a U.S. regulatory critique of so-identified as accelerated approvals, a controversial approach that has been utilised to hasten availability of treatments for critical conditions.
The newest reversal issues Tecentriq, a Roche (RHHBY) drug that was granted accelerated approval in 2016 to handle bladder cancer, but a demo to affirm the rewards subsequently showed it failed to boost in general survival. Very last month, AstraZeneca (AZN) withdrew a bladder cancer indication for Imfinzi right after a observe-up trial also showed the drug unsuccessful to increase general survival.
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