After Failed Confirmatory Trial, Gilead Withdraws US Accelerated Approval Of Trodelvy As Bladder Cancer treatment
Portfolio Pulse from Vandana Singh
Gilead Sciences is withdrawing the US accelerated approval for Trodelvy as a bladder cancer treatment after a failed confirmatory trial. The decision, made with the FDA, does not affect other approved uses of Trodelvy. The TROPiCS-04 study did not meet its primary endpoint, impacting Gilead's stock slightly.
October 18, 2024 | 6:34 pm
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NEUTRAL IMPACT
Merck & Co is involved in a Phase 3 trial with Gilead's Trodelvy in combination with Keytruda for lung cancer. This trial is ongoing and unrelated to the recent withdrawal of Trodelvy's approval for bladder cancer.
Merck's involvement with Trodelvy is in a separate trial for lung cancer, which is not impacted by the withdrawal of Trodelvy's approval for bladder cancer. Therefore, the news has a neutral impact on Merck.
CONFIDENCE 80
IMPORTANCE 40
RELEVANCE 30
NEGATIVE IMPACT
Gilead Sciences is withdrawing the US accelerated approval for Trodelvy as a bladder cancer treatment after a failed confirmatory trial. This decision, made in consultation with the FDA, does not affect other approved uses of Trodelvy.
The withdrawal of Trodelvy's accelerated approval for bladder cancer is a significant regulatory setback for Gilead, as it failed to meet the primary endpoint in the confirmatory trial. This could impact investor sentiment negatively in the short term, as reflected by the slight drop in stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100