Press release
European Commission Approves Gilead’s Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer
-- Approval Based on Clinically Meaningful Overall Survival Benefit Demonstrated in the TROPiCS-02 Study in Pre-Treated HR+/HER2- (IHC 0, IHC 1+ or IHC
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- Approval Based on Clinically Meaningful Overall Survival Benefit Demonstrated in the TROPiCS-02 Study in Pre-Treated HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) Metastatic Breast Cancer vs. Physician’s Choice of Chemotherapy --\n\n\n-- Trodelvy Now Indicated in Both Pre-Treated HR+/HER2- Metastatic Breast Cancer and Second-Line Metastatic Triple-Negative Breast Cancer in Europe --\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) approved Trodelvy® (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.\n\n\nThe approval by the European Commission follows the positive opinion of the Committee for Medicinal Products and is based on the Phase 3 TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02). Trodelvy also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy (21% versus 7%).\n\n\n\"The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated HR+/HER2- metastatic breast cancer.”\n\n\n“Trodelvy could change the outlook for women with pre-treated HR+/HER2- metastatic breast cancer by replacing the standard-of-care chemotherapy that has been their only option for decades,” said Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology. “We look forward to working with European authorities to ensure access for these patie...