Benzinga | Nov 23, 2021 01:03PM EST

Gilead's Trodelvy Approved In Europe For Aggressive Form Of Breast Cancer

The European Commission has approved Gilead Sciences Inc's (NASDAQ: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.