UPDATED: Roche withdraws Tecentriq in bladder cancer amid FDA's sweeping review on accelerated approvals
The “industry-wide review of accelerated approvals” that’s been making waves in the checkpoint field has reached Roche.
With prodding from the FDA, the Swiss pharma giant says it’s pulling a bladder cancer indication for Tecentriq in the US — more than three years after it conceded a stunning failure in the original confirmatory study.
Like his counterparts at Bristol Myers Squibb, AstraZeneca and Merck, all of which have disclosed withdrawals in recent weeks, Roche R&D chief Levi Garraway praised the accelerated approval program and highlighted the PD-L1 drug’s benefits in other cancer types despite the “disappointing” decision.
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