US FDA grants priority review for AstraZeneca’s olaparib

The US Food and Drug Administration has granted Priority Review for Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) olaparib for ovarian cancer.

The drug is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits DNA repair pathway deficiencies to preferentially kill cancer cells. It is being reviewed in ovarian cancer patients who have a BRCA mutation and whose cancer has relapsed following a complete or partial response to platinum-based chemotherapy. Patients with the BRCA mutation are being identified through a companion diagnostic test.

The Priority Review status means that the FDA intends to take action on the olaparib application within six months (compared to 10 months under standard review, with a Prescription Drug User Fee Act (PDUFA) date of October 3.