Gilead's Sacituzumab Govitecan Gets Positive CHMP Opinion in Breast Cancer
October 15 2021 - 8:52AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 15, 2021 08:37 ET (12:37 GMT)
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