logo
Plus   Neg
Share
Email

FDA Approves Gilead's Trodelvy To Treat Metastatic Triple-Negative Breast Cancer

Gilead Sciences Inc. (GILD) said that the U.S. Food and Drug Administration has granted full approval to Trodelvy or sacituzumab govitecan-hziy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer or TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy significantly reduced the risk of death by 49% compared with single-Agent Chemotherapy in the phase 3 ASCENT study.

Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival or PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy.

The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a phase 1/2 study.

Today's approval expands the previous Trodelvy indication to include treatment in adult patients with unresectable locally advanced or metastatic Triple-Negative Breast Cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The Trodelvy U.S. Prescribing Information has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT