AstraZeneca has received US and EU regulatory approval for Lynparza (olaparib) capsules (400mg twice daily) to treat advanced ovarian cancer. The US Food and Drug Administration approved Lynparza as a monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The European Commission also approved olaparib in the European Union as a therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated serous ovarian cancer. It was approved in the EU for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in complete response or partial response to platinum-based chemotherapy.

Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that targets tumor DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer as detected by an FDA approved companion diagnostic test, BRACAnalysis CDx, which detects the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10% to 15% of all ovarian cancer is associated with these hereditary BRCA mutations. BRACAnalysis CDx is manufactured by and performed at Salt Lake City, Utah-based Myriad Genetic Laboratories, Inc.

Olaparib was approved under the FDA's Accelerated Approval program based on existing objective response rate and duration of response data. Continued approval for this indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials.

Source: AstraZeneca (US approval),  AstraZeneca (EU approval) and FDA