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May 10, 2018

AstraZeneca announces EU approval of Lynparza for ovarian cancer

AstraZeneca and Merck have announced the approval of Lynparza (olaparib) by the European Medicines Agency (EMA) to treat platinum-sensitive relapsed ovarian cancer.

AstraZeneca and Merck have announced the approval of Lynparza (olaparib) tablets by the European Medicines Agency (EMA) to treat platinum-sensitive relapsed ovarian cancer.

The approval covers a 300mg twice daily dose of the drug as a maintenance therapy for high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer in patients who are in complete or partial response to platinum-based chemotherapy, irrespective of BRCA status.

Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor and has been co-developed by AstraZeneca and Merck under a global strategic oncology alliance signed by the companies in July last year.

The drug was previously approved in Europe to be administered as a capsule for the treatment of BRCA-mutated platinum-sensitive relapsed ovarian cancer.

“With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer a chance to achieve long-term disease control.”

The tablet formulation of the drug reduces dosing from eight capsules twice daily to two daily tablets.

AstraZeneca executive vice-president and Oncology Business Unit head Dave Fredrickson said: “With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile.”

The approval is based on the results obtained from two randomised trials conducted in 295 and 265 platinum-sensitive relapsed ovarian cancer subjects, respectively.

The drug demonstrated a decreased risk of disease progression or death when compared to placebo.

Recently, another application was submitted to the EMA seeking approval of Lynparza tablets to treat patients with BRCA-mutated, HER2-negative metastatic breast cancer.

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