30th Sep 2013 06:24
LONDON (Alliance News) - AstraZeneca Plc (AZN, AZN.L) said the European Medicines Agency or EMA has accepted its Marketing Authorisation Application or MAA for olaparib, an investigational poly ADP-ribose polymerase or PARP inhibitor, for the maintenance treatment of patients with BRCA mutated platinum-sensitive relapsed serous ovarian cancer.
The MAA filing was based on Phase II trial 19 data, a randomized, double-blind, placebo-controlled, Phase II study, which evaluated maintenance treatment with olaparib 400 mg twice daily versus placebo in platinum-sensitive relapsed serous ovarian cancer patients who had received previous treatment with at least two platinum regimens and were in a maintained partial or complete response following their last platinum regimen.
The primary endpoint was progression-free survival by Response Evaluation Criteria in Solid Tumors or RECIST guidelines. Secondary endpoints included time to progression by CA-125 or RECIST, overall survival and safety. A pre-defined subgroup analysis was conducted of patients who have BRCA mutations, which showed the treatment benefit of olaparib was greater in patients with BRCA mutated ovarian cancer.
Olaparib has the potential to be the first PARP inhibitor available for patients with BRCA mutated platinum-sensitive relapsed serous ovarian cancer.
Copyright RTT News/dpa-AFX
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