Gilead Scores Fifth Approval For Trodelvy In Triple-Negative Breast Cancer, This Time In Canada

Health Canada has approved Gilead Sciences Inc's GILD Trodelvy (sacituzumab govitecan-hziy) for previously treated breast cancer patients.
The approval comes for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease.
Canada joins Australia, Great Britain, Switzerland, and the U.S., which have approved Trodelvy for use under Project Orbis.
Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2, a protein located on the surface of cells, is overexpressed in TNBC and other solid tumors.
The European Medicines Agency also validated a Marketing Authorization Application for Trodelvy in March. Regulatory review is also underway in Kazakhstan, Saudi Arabia, and Singapore via Everest Medicines licensing partner.
These approvals were supported by data from the Phase 3 ASCENT study, in which Trodelvy showed a 57% reduction in the risk of disease worsening or death and improved median PFS in patients regardless of brain metastasis to 4.8 months from 1.7 months with chemotherapy.
Related content: Benzinga's Full FDA Calendar.
Price Action: GILD stock is down 0.71% at $69.91 during the premarket session on the last check Tuesday.