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19-04-2021 | FDA | News


FDA approves sacituzumab govitecan for advanced urothelial cancer

Hannah Kitt

medwireNews: Sacituzumab govitecan has been given accelerated approval from the US FDA for previously treated locally advanced or metastatic urothelial cancer.

The Trop-2-directed antibody–drug conjugate is indicated for patients who have progressed on a platinum-based chemotherapy regimen and a PD-1 or PD-L1 inhibitor. However, “[c]ontinued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” states the press release.

The decision was based on results from the TROPHY U-01 trial, which showed an objective response rate of 27.7% – consisting of complete responses in 5.4% of patients – and a median duration of response of 7.2 months in this patient population.

According to the prescribing information, sacituzumab govitecan should be given at a dose of 10 mg/kg on days 1 and 8 of each 21-day treatment cycle, which is also the dose recommended for use in the refractory metastatic triple-negative breast cancer setting.

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