Gilead To Withdraw U.S. Accelerated Approval For Trodelvy In Metastatic Urothelial Cancer After Consultation With FDA; Decision Follows TROPiCS-04 Study Not Meeting Overall Survival Endpoint; Other Trodelvy Indications Remain Unaffected
Portfolio Pulse from Benzinga Newsdesk
Gilead Sciences has decided to withdraw the U.S. accelerated approval for its drug Trodelvy in treating metastatic urothelial cancer after the TROPiCS-04 study failed to meet the overall survival endpoint. Other indications for Trodelvy remain unaffected.

October 18, 2024 | 12:37 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Gilead Sciences is withdrawing the U.S. accelerated approval for Trodelvy in metastatic urothelial cancer due to a study not meeting its endpoint. This decision does not affect other uses of Trodelvy.
The withdrawal of accelerated approval for Trodelvy in a specific cancer type could negatively impact Gilead's stock in the short term due to potential concerns about the drug's efficacy in this indication. However, since other indications for Trodelvy remain unaffected, the overall impact may be limited.
CONFIDENCE 95
IMPORTANCE 70
RELEVANCE 90