European Commission Approves Olaparib as Monotherapy for Advanced Breast Cancer

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AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

AstraZeneca and MSD (known as Merck & Co. in the United States and Canada) have announced the European Commission’s (EC) approval of Lynparza (olaparib) as a monotherapy in the treatment of adults with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.

In the companies’ April 10, 2019 announcement, it was revealed that the licensed indication recommends that patients should have undergone prior treatment with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting (unless they were unsuitable for these treatments) before treatment with Lynparza. For patients with hormone receptor (HR)-positive breast cancer, the recommendation is for Lynparza to be used after progression on or after endocrine therapy or if considered unsuitable for endocrine therapy.

“With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer,” said Dave Fredrickson, executive vice-president, Oncology at AstraZeneca. “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.”

The EC’s approval was based upon data from the randomized open-label, Phase III OlympiAD trial, which compared Lynparza with a choice of three different forms of chemotherapy (capecitabine, eribulin, or vinorelbine), decided upon by the physician. Results of the trial demonstrated that Lynparza reduced the risk of disease progression or death by 42% compared with chemotherapy.


“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,” added Roy Baynes, senior vice-president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories. “We look forward to making this new option available across the EU, where we hope it will improve outcomes for many patients.”

Source: AstraZeneca