Gilead Sciences Voluntarily Withdraws Trodelvy’s Accelerated Approval for Urothelial Cancer

Gilead Sciences has announced the voluntary withdrawal of the accelerated approval for its cancer drug Trodelvy in treating locally advanced or metastatic urothelial cancer in the US. This decision, made in consultation with the FDA, follows results from a confirmatory Phase 3 study that did not meet the primary endpoint of overall survival. The withdrawal does not affect other approved indications for Trodelvy within or outside the US.

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