• The FDA has approved Gilead Sciences Inc's (NASDAQ: GILD) Trodelvy (sacituzumab govitecan-hziy) for adult patients with advanced or metastatic breast cancer.

• The approval covers unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

• The approval is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study.

• Trodelvy is recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN).

• In the TROPiCS-02 study, Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy.

• Trodelvy also demonstrated a 34% reduction in disease progression or death risk.

• Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy.

• In 2022, Trodelvy generated sales of $680 million, 79% Y/Y, reflecting the continued adoption in metastatic triple-negative breast cancer in the U.S. and Europe.

• Price Action: GILD shares are up 4.14% at $84.76 on the last check Friday.

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article Gilead Sciences' Trovelvy Scores FDA Approval For Advanced/Metastatic Breast Cancer Setting originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.