Gilead Sciences Canada, Inc. announced that Health Canada has issued a Notice of Compliance for TRODELVY® (sacituzumab govitecan) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This decision is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study.
"HR+/HER2- metastatic breast cancer patients have limited treatment options, and the market authorization of TRODELVY is a step in the right direction in providing an additional therapy for Canadian patients," said Dr. Karen A. Gelmon, a Professor of Medicine at the University of British Columbia and a Medical Oncologist at BC Cancer. "Nearly all patients with HR+/HER2- advanced breast cancer will eventually develop resistance to endocrine-based therapies and once they have progressed, their primary treatment option is single-agent chemotherapy. At this point, it is common for persons to receive multiple lines of chemotherapy regimens, with decreasing responses with each new treatment. TRODELVY in this indication with its efficacy is welcome news to patients and to the oncology community."
"Though many are living longer than before, when living with uncurable breast cancer, you always want to know what the next treatment will be if you need it. And for the metastatic breast cancer community, they hope that next treatment will be one that helps them live better and longer than the prognosis offered with palliative chemotherapy. We need to make sure newer, more effective treatments are available to Canadians now, when people need them" said MJ DeCoteau, Founder and Executive Director at Rethink Breast Cancer.
The market authorization is supported by results from 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; [HR]=0.789; 95% CI: 0.646, 0.964; p=0.0200). TRODELVY also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.661; 95% CI: 0.529, 0.826; 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%). This was an exploratory analysis as formal statistical testing was not conducted.
"We are pleased that TRODELVY now has the potential to bring new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the critical role TRODELVY is already playing for people with metastatic triple-negative breast cancer," said Christophe Griolet, Vice President and General Manager, Gilead Sciences Canada, Inc. "On behalf of Gilead, we thank the physicians, patients and their families and caregivers for placing their trust in our clinical trial, and in ultimately helping to provide new and innovative treatments to Canadians."
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