On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) announced plans to voluntarily withdraw the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy; SG) for adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
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The decision was made in consultation with the FDA and does not affect the other approved Trodelvy indications within or outside the U.S.
Trodelvy was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from the global Phase 2, single-arm TROPHY-U-01 study.
Continued approval for this indication was contingent on verification and description of clinical benefit in the confirmatory TROPiCS-04 study.
In May, Gilead Sciences announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC).
The TROPiCS-04 study evaluated Trodelvy (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians' choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.
The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC), which has demonstrated meaningful survival advantages in both 2L+ metastatic TNBC and pre-treated HR+/HER2—metastatic breast cancer.
More than 20 ongoing clinical trials are evaluating Trodelvy as a monotherapy and in combination with other agents across a range of solid tumors, including lung and gynecological cancers.
Trodelvy's is being evaluated in a Phase 3 EVOKE-03 trial in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (Pembrolizumab) in PD-L1-high Metastatic Non-small Cell Lung Cancer.
Started in February 2023, the trial is expected to conclude in January 2027.
Price Action: GILD stock is down 0.67% at $86.78 at last check Friday.
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