October 24, 2014
By Riley McDermid, BioSpace.com Breaking News Staff
AstraZeneca said today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended its new drug Lynparza (olaparib) as a therapy for patients with a genetically mutated form of ovarian, fallopian tube or primary peritoneal cancer.
The next regulator to review the drug will be the European Commission, which will make a decision on whether or not to roll out the drug to the entire European Union, where ovarian cancer is the fifth most commonly diagnosed cancer in women and the sixth leading cause of cancer death among women.
The lifetime risk of developing ovarian cancer climbs 40 percent in women who have the BRCA1 or BRCA2 gene mutations.
The positive CHMP opinion was based on the results from Study 191, a Phase II clinical trial that used olaparib on platinum sensitive relapsed high grade serous cancer patients with BRCA-mutated ovarian cancer. Its data showed that olaparib significantly prolonged progression free survival compared with a placebo in patients with BRCA-mutated ovarian cancer, with a longer survival rate of 11.2 months versus 4.3 months.
Lynparza is used in conjunction with chemotherapy on patients who have are in response (complete or partial) to platinum-based chemotherapy. Olaparib works by rewiring the DNA in tumors to selectively kill cancer cells.
“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, in a statement.
“We are committed to investigating the full potential of olaparib and have a number of studies underway in multiple tumor types including breast and gastric cancer,” he said.
The European Commission’s final decision would make Lynparza available to all 28 European Union member countries plus Iceland, Norway and Liechtenstein. It would then become the first PARP inhibitor available in Europe for the treatment of platinum sensitive relapsed BRCA-mutated high grade serous ovarian cancer.
