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UPDATE: AstraZeneca Gets EMA Marketing Approval For Lynparza

Fri, 24th Oct 2014 12:32

LONDON (Alliance News) - UK pharmaceutical company AstraZeneca PLC has received approval from the European Medicines Agency for its drug Lynparza, paving the way for the UK pharmaceutical company to start marketing the treatment to ovarian cancer patients.

The EMA's Committee for Medicinal Products for Human Use, or CHMP, said the drug, also known as olaparib, can be used as a monotherapy to treat patients responding to platinum-based chemotherapy treatment.

"We are delighted that the CHMP has recommended Lynparza as a first-in-class treatment option for women with BRCA-mutated ovarian cancer and we look forward to the European Commission's decision once it completes its review," said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. "We are committed to investigating the full potential of olaparib and have a number of studies underway in multiple tumour types including breast and gastric cancer."

The company said the positive opinion was based on the results from a Phase II clinical trial of 265 patients that evaluated the efficacy and safety of olaparib compared to placebo in platinum sensitive relapsed high grade serous ovarian cancer patients. The study showed that olaparib significantly prolonged progression free survival compared with a placebo in patients.

The drug is being trailed in Phase III tests on ovarian cancer patients and is also in Phase III studies for gastric and breast cancer patients.

At 1222 BST, AstraZeneca shares were down 0.5% at 4,313 pence a share, up from earlier lows.

By Ian Edmondson

Copyright 2014 Alliance News Limited. All Rights Reserved.

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