Gilead Sciences, Inc. that Health Canada has approved Trodelvy for the treatment of 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 United States among the countries that have approved Trodelvy for use under Project Orbis. Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) with international regulatory authorities as a global collaborative review program for high impact oncology marketing applications across participating countries. 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 as well as other solid tumors. Beyond the Project Orbis regulatory approvals, the European Medicines Agency validated a Marketing Authorization Application for Trodelvy in March and regulatory review is also underway in Kazakhstan and Saudi Arabia, as well as Singapore via licensing partner, Everest Medicines.