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Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, .

The decision was made in consultation with the FDA and does not affect the antibody-drug conjugate's other indications, the company said.

A Trop-2-directed antibody, sacituzumab govitecan was granted accelerated approval for urothelial cancer in 2021 -- for patients with locally advanced or metastatic disease previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor -- based on overall response rate (27%) and duration of response (median 5.9 months) data from the phase II .

Continued approval was contingent on demonstration of clinical benefit in a confirmatory trial.

But in the phase III TROPiCS-04 trial, sacituzumab govitecan in a similar patient population (OS) versus single-agent chemotherapy (physician's choice of paclitaxel, docetaxel, or vinflunine). Despite a numerical improvement in OS that favored sacituzumab govitecan, according to Gilead, deaths due to adverse events were higher with the Trop-2-directed antibody -- mostly neutropenic complications early in treatment. Data from TROPiCS-04 will be presented at a future medical meeting.

Sacituzumab govitecan carries traditional approval for previously treated locally advanced or metastatic breast cancer, where the drug has demonstrated an OS benefit: both in triple-negative disease and .

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