Gilead withdraws bladder cancer drug Trodelvy in US
Bengaluru: Gilead Sciences said on Friday it was voluntarily withdrawing its drug, Trodelvy, for previously treated patients with a type of bladder cancer after consultation with the U.S. health regulator.
The U.S. Food and Drug Administration had granted accelerated approval to Trodelvy, an antibody-drug conjugate, for metastatic urothelial cancer in 2021, while its continued approval was dependent on results of a confirmatory trial.
The drug, however, failed to improve survival for patients with advanced bladder cancer in the trial.
Shares of the drugmaker fell 1.3% to $86.25 in premarket trading
The decision does not affect approval for Trodelvy for other patients within or outside of the U.S., the company said.
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