CHMP recommends sacituzumab govitecan as monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer.- Gilead Sciences.

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. Sacituzumab govitecan is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a protein located on the surface of cells and is overexpressed in TNBC and many other tumors.

The positive opinion is supported by results from the Phase III 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 (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001).sacituzumab govitecan also reduced the risk of death by 49% and improved median overall survival to 11.8 months vs. 6.9 months with physician’s choice of chemotherapy (hr: 0.51; 95% ci: 0.41-0.62; p><0.0001).></0.0001).></0.0001).sacituzumab>