Acceletd Approval Trodelvy - Advanced/Metastatic Urothelial Cancer April 2021

U.S. FDA Grants Accelerated Approval to Trodelvy forthe Treatment of Metastatic Urothelial Cancer

Gilead Sciences, Inc. Apr 13, 2-21 today announced that theU.S. 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 a 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% of those treated with Trodelvy responded to treatment, with
5.4% experiencing a complete response and 22.3% experiencing a partial
response. The median duration of response was 7.2 months (95% CI: 4.7-8.6). The
Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or
life-threatening neutropenia and severe diarrhea; see below for Important
Safety Information.More at: www.drugs.com/newdrugs/u-s-fda-grants-accelerated-approval-trodelvy-metastatic-urothelial-cancer-5486.html?utm_source=ddc&utm_medium=email&utm_campaign=Monthly+News+Roundup+++Vol+200++April+2021&hash2=afd27105b58855306dfc3211f2821312