Gilead Sciences Inc. (GILD) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA adopted a positive opinion for sacituzumab govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer or TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.
The final European Commission decision on the Marketing Authorization Application for sacituzumab govitecan is anticipated later in 2021.
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. The five-year survival rate for this sub-type is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease.
The positive opinion is supported by results from the Phase 3 ASCENT study, where sacituzumab govitecan showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death and improved median progression-free survival (PFS) to 4.8 months from 1.7 months seen with physician's choice of chemotherapy alone among all randomized patients, which included those with and without brain metastases.
Sacituzumab govitecan (under the trade name Trodelvy) is approved in Australia, Canada, Great Britain, Switzerland, and the United States in metastatic TNBC, and review is also underway in Singapore and China through Everest Medicines.
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