Benzinga | Sep 28, 2021 09:27AM EDT

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

* Health Canada has approved Gilead Sciences Inc's (NASDAQ: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.