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AstraZeneca PLC announces FDA Advisory Committee votes on olaparib

Thursday, 26 Jun 2014 02:00am EDT 

AstraZeneca PLC:Says US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11 to 2 that current evidence from clinical studies does not support.Says an accelerated approval for use of olaparib as maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy.ODAC provides the FDA with independent, expert advice and recommendations, however the final decision regarding approval is made by the FDA.Filed US regulatory submission for olaparib in Feb. 2014.FDA granted priority review status for the NDA in April and set a Prescription Drug User Fee Act (PDUFA) action date of Oct. 3.NDA filing was based on subgroup analysis of Phase II data recently published in Lancet Oncology1.Phase II study was a randomised, double-blind, placebo-controlled trial which evaluated olaparib versus placebo as maintenance treatment in platinum-sensitive relapsed serous ovarian cancer patients.In addition, as part of its commitment to bring the potential benefits of olaparib to ovarian cancer patients, AstraZeneca has initiated and is committed to complete the Phase III SOLO programme.Designed to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in ovarian cancer patients who have a BRCA mutation who are in complete or partial response following platinum-based chemotherapy in the relapsed setting. 

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