BioCentury
ARTICLE | Financial News

FDA extends review for AZ's olaparib

August 1, 2014 12:41 AM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) disclosed in its 2Q14 financial results on Thursday that FDA extended the PDUFA date by three months for cancer product olaparib. The PDUFA date is now Jan. 3, 2015; the previous date was Oct. 3. According to AZ, FDA is reviewing additional data the company submitted. AZ is seeking accelerated approval of the poly(ADP-ribose) polymerase (PARP) inhibitor as maintenance treatment of platinum-sensitive relapsed ovarian cancer in patients with germline breast cancer early onset (BRCA) mutations who are responding to platinum-based chemotherapy.

Last month, FDA's Oncologic Drugs Advisory Committee voted 11-2 that safety and efficacy data did not support accelerated approval of olaparib and that the agency should delay considering approval until results are available from an ongoing confirmatory Phase III trial (see BioCentury, June 30). ...