The European Commission has approved Gilead Sciences Inc's GILD Trodelvy (sacituzumab govitecan) as monotherapy for triple-negative breast cancer (TNBC).
- The approval for the antibody-drug conjugate covers adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies.
- The EC's decision is supported by results from the Phase 3 ASCENT study, where Trodelvy reduced the risk of death by 49% and improved median overall survival to 11.8 months versus 6.9 months with the physician's choice of chemotherapy.
- These data also showed a statistically significant and clinically meaningful 57% reduction in the risk of death or disease worsening and improved median progression-free survival (PFS) to 4.8 months from 1.7 months seen with physician's choice of chemotherapy.
- Price Action: GILD shares are up 0.47% at $70.30 during the market session on the last check Tuesday.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in