(Reuters) – Gilead Sciences said on Friday it was voluntarily withdrawing its drug Trodelvy for previously treated patients with a type of bladder cancer after consulting with a U.S. health regulator.
The U.S. Food and Drug Administration granted accelerated approval in 2021 to Trodelvy, an antibody-drug conjugate for the treatment of metastatic urothelial cancer, with continued approval of the drug contingent on results from a confirmatory study.
However, in the study, the drug did not improve the survival of patients with advanced bladder cancer.
Shares of the drugmaker fell 1.3% to $86.25 in pre-market trading.
The decision does not affect the approval of Trodelvy for other patients in the United States and elsewhere, the company said.
