ARTICLE | Clinical News

Lynparza olaparib regulatory update

December 22, 2014 8:00 AM UTC

FDA and the European Commission approved Lynparza olaparib from AstraZeneca to treat ovarian cancer. FDA granted accelerated approval to the poly(ADP-ribose) polymerase (PARP) inhibitor to treat deleterious or suspected deleterious germline breast cancer early onset (BRCA)-mutated advanced ovarian cancer in patients who have been treated with =3 prior lines of chemotherapy. FDA concurrently approved a PMA from Myriad Genetics Inc. (NASDAQ:MYGN, Salt Lake City, Utah) for BRACAnalysis CDx as the only companion diagnostic for Lynparza. ...