FDA Seeking Comments on Olaparib by June 11
The Food and Drug Administration is seeking comments by June 11, 2014 on its review for Olaparib approval. Olaparib is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits DNA repair pathway deficiencies to preferentially kill cancer cells. AstraZeneca, the company that manufactures the drug, has submitted an application to the FDA for approval of Olaparib specifically for maintenance therapy for women with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy.
The hearing itself will take place on June 25, 2014. OCRF Scientific Advisory Committee member Ursula Matulonis, MD will attend the meeting to help present the clinical trial data in support of the filing.
Public comments can be submitted ahead of time, but by June 11, 2014, via email or regular mail.