AstraZeneca and Merck's Breast Cancer Drug Gains EU Approval

02:48 04/15/2019

The European Commission has approved AstraZeneca plc AZN AZN  and partner Merck's MRK  PARP inhibitor, Lynparza (olaparib).

Lynparza has been approved by the EU as a monotherapy, for a new patient population suffering germline BRCA-mutated HER2-negative locally-advanced/metastatic breast cancer, who were previously treated with chemotherapy.

Lynparza is the first approved PARP-inhibitor for treating metastatic breast cancer in Europe. The drug is already marketed in the United States for the breast cancer indication and is presently marketed for advanced ovarian cancer in the States, the EU and many other countries.

The EU's approval of Lynparza means that it can now be used to treat breast cancer patients, who have previously been treated with an anthracycline and a taxane. It can also be used in those who have progressed after being treated with endocrine therapy or are considered unsuitable for endocrine therapy.

Dave Fredrickson, executive vice president, oncology, AstraZeneca, remarked, “With this approval, LYNPARZA provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer. It also reinforces the importance of testing for biomarkers, including BRCA, hormone receptor and HER2 expression, helping physicians to make the most informed treatment decisions for patients.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, commented, “In the OlympiAD trial, which supported this approval, LYNPARZA demonstrated a meaningful improvement in progression-free survival compared to chemotherapy in patients with germline BRCA-mutated metastatic breast cancer. We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients.”

According to AstrasZeneca's press release, the OlympiAD trial 'was a global, randomised, open-label, multi-centre Phase III trial of 302 patients, assessing the efficacy and safety of Lynparza tablets (300mg twice daily) compared to the physician’s choice of chemotherapy (capecitabine, eribulin or vinorelbine); 205 patients were randomised to receive Lynparza and 97 patients were randomised to receive chemotherapy. Patients in the OlympiAD trial had germline BRCA1- and/or BRCA2-mutated, HER2-negative (HR-positive or triple negative) breast cancer and received Lynparza for treatment in the metastatic setting.'

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