AstraZeneca and Merck’s Breast Cancer Drug Lynparza Gets EU Approval

AstraZeneca plc AZN and partner Merck announced this week that the European Commission has approved the two companies’ PARP inhibitor, Lynparza (olaparib).

Lynparza has been approved 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.

Lynparza 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.

With the approval from the EU, Lynparza 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.”

Disclaimer: We have no position in AstraZeneca plc (NYSE: AZN) nor Merck & Co., Inc. (NYSE: MRK) and have not been compensated for this article.