Gilead gets US FDA Accelerated Approval for Trodelvy to treat metastatic urothelial cancer

Gilead Sciences announced that the US Food and Drug Administration (FDA) has 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 platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.

Of the 112 patients who were evaluable for efficacy, 27.7 per cent of those treated with Trodelvy responded to treatment, with 5.4 per cent experiencing a complete response and 22.3 per cent experiencing a partial response. The median duration of response was 7.2 months (95% CI: 4.7-8.6).

Trodelvy’s safety profile in the TROPHY study is consistent with previous observations in metastatic UC and other tumor types. Among all evaluable treated metastatic UC patients (n=113), the most common (≥25%) adverse reactions were diarrhea (72%), anemia (71%), fatigue (68%), neutropenia (67%), nausea (66%), alopecia (49%), decreased appetite (41%), constipation (34%), vomiting (34%) and abdominal pain (31%). Adverse reactions leading to treatment discontinuation occurred in 10% of those receiving Trodelvy, with 4% discontinuing treatment due to neutropenia.

“Today’s accelerated approval is thanks to the patients and healthcare professionals involved in the TROPHY study, and we appreciate their partnership,” said Merdad Parsey, Chief Medical Officer, Gilead Sciences.