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, but 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.
The back-to-back reversals emerge after sustained debate over accelerated approval, which the Food and Drug Administration initiated in 1992 for medicines that fill an unmet medical need. Approval is based on a surrogate endpoint, which allows the agency to act faster, an issue that has motivated patient groups to regularly push the FDA.