Gilead Sciences Voluntarily Withdraws Trodelvy’s Accelerated Approval for Urothelial Cancer
Gilead Sciences, Inc. (GILD) has made the decision to voluntarily withdraw the accelerated approval of its cancer drug Trodelvy (sacituzumab govitecan-hziy; SG) for the treatment of adult patients with locally advanced or metastatic urothelial cancer in the United States. This withdrawal applies specifically to patients who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
The decision was made in close consultation with the Food and Drug Administration (FDA) and does not affect the other approved indications for Trodelvy within or outside the US. It’s important to note that Trodelvy had initially received accelerated approval for metastatic urothelial cancer in 2021. This approval was based on promising data from the global Phase 2, single-arm TROPHY-U-01 study, which highlighted the drug’s tumor response rate and duration of response.
However, continued approval for this indication was contingent upon the verification and description of clinical benefit in a confirmatory study, TROPiCS-04. The results from this confirmatory Phase 3 study, announced by Gilead Sciences in May, revealed that the study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
While this specific indication for Trodelvy has been withdrawn, the drug continues to hold promise in other areas of cancer treatment. It’s the first approved Trop-2-directed antibody-drug conjugate (ADC) and has demonstrated significant survival benefits in both 2L+ metastatic TNBC (triple-negative breast cancer) and pre-treated HR+/HER2—metastatic breast cancer.
Moreover, Gilead Sciences is actively pursuing further clinical trials evaluating Trodelvy, both as a monotherapy and in combination with other agents, across a range of solid tumors, including lung and gynecological cancers. One notable example is the Phase 3 EVOKE-03 trial, which began in February 2023, investigating the use of Trodelvy in combination with Merck & Co Inc’s (MRK) Keytruda (Pembrolizumab) for PD-L1-high Metastatic Non-small Cell Lung Cancer. This trial is expected to conclude in January 2027.
The news of the withdrawal led to a slight decline in GILD stock, which was down 0.67% at $86.78 at the end of the trading day on Friday.