FDA accelerated approval for Trodelvy in advanced urothelial cancer

Following swiftly on approval for metastatic triple-negative breast cancer (mTNBC), the US Food and Drug Administration has also granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

The approval, which came six weeks earlier that the FDA goal date, was granted to Immunomedics, a company that was acquired last year by Gilead Sciences (Nasdaq: GILD) in a $21 billion deal. Cowan analyst Phil Nadeau said Trodelvy is expected to have $4 billion in peak sales.

“Today’s accelerated approval is thanks to the patients and healthcare professionals involved in the TROPHY study, and we appreciate their partnership,” said Dr Merdad Parsey, chief medical officer, Gilead Sciences, adding: “This achievement, coupled with last week’s full FDA approval in unresectable locally advanced or metastatic triple-negative breast cancer, underscores our commitment toward rapidly delivering Trodelvy to patients facing some of the most difficult-to-treat cancers.”