Posted by Michael Wonder on 18 Jun 2019
Lynparza (olaparib) approved in the EU for use as first-line maintenance therapy in patients with BRCA mutated advanced ovarian cancer
18 June 2019 - Lynparza is the only PARP inhibitor approved in the EU for this indication.
AstraZeneca and Merck today announced that the European Commission has approved Lynparza as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (BRCAm) (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
The EU approval was based on data from the randomised, double-blinded Phase 3 SOLO-1 trial which evaluated Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following first-line platinum-based chemotherapy.
