Posted by Michael Wonder on 26 Mar 2021
EMA validates marketing authorisation application for sacituzumab govitecan-hziy for the treatment of metastatic triple negative breast cancer
25 March 2021 - Agency grants accelerated assessment based on positive results of Phase 3 ASCENT trial.
Gilead Sciences today announced that the EMA has validated the marketing authorisation application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease.
