FDA gives Accelerated Approval to Lynparza for Ovarian Cancer with defective BRCA genes-AstraZeneca

The FDA has granted accelerated approval to Lynparza (olaparib) from AstraZeneca, a new drug treatment for women with advanced Ovarian Cancer associated with defective BRCA genes, as detected by an FDA-approved test. Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated Ovarian Cancer that is associated with defective BRCA genes.

The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with COvarian cancer.

In June, Lynparza was reviewed by the FDA’s Oncologic Drugs Advisory Committee for potential use as maintenance therapy (treatment given to keep cancer from returning). The committee advised the agency in a vote of 11 to 2 that the data did not support Lynparza’s accelerated approval for this use. After the meeting, the company submitted additional information supporting Lynparza’s use for a different use: in patients with gBRCAm-associated Ovarian Cancer who have received three or more chemotherapy treatments.