Gilead's Sacituzumab Govitecan Gets Positive CHMP Opinion in Breast Cancer

By Michael Dabaie

Gilead Sciences Inc. said the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for sacituzumab govitecan as monotherapy in unresectable or metastatic triple-negative breast cancer.

Gilead said it anticipates the final European Commission decision on the marketing authorization application for sacituzumab govitecan later in 2021.

The pharma company said TNBC is the most aggressive type of breast cancer and accounts for about 15% of all breast cancers.

The positive opinion is supported by results from the Phase 3 Ascent study, where sacituzumab govitecan showed a 57% reduction in the risk of disease worsening or death and improved median progression-free survival.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

10-15-21 0837ET