ARTICLE | Clinical News

Lynparza olaparib regulatory update

October 27, 2014 7:00 AM UTC

EMA's CHMP recommended approval of Lynparza olaparib from AstraZeneca as monotherapy for maintenance treatment of relapsed, platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer in patients with breast cancer early onset (BRCA) mutations who have responded to platinum-based chemotherapy. CHMP's opinion was based on data from a pivotal Phase II trial, and the committee recommends a postmarketing requirement that AZ provide data from ongoing trials as soon as they become available. The poly(ADP-ribose) polymerase (PARP) inhibitor has Orphan Drug designation in the U.S. and EU to treat ovarian cancer. ...