AstraZeneca's Lynparza gains FDA approval

The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

This was good news for AstraZeneca, as earlier this year the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11 to two that current evidence from clinical studies does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA (gBRCA) mutation (The Pharma Letter June 26).

Concurrent with this action on Friday, the FDA approved the BRACAnalysis CDx (Myriad Genetics) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes.

Follows on the heels of EU approval