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AstraZeneca’s Lynparza approved in EU

David Fredrickson

AstraZeneca and MSD have announced that the European Commission has approved Lynparza (olaparib) as a monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (gBRCAm), and who have human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer.

“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,” says Dave Fredrickson, Executive Vice President, Oncology, AstraZeneca.

Under the licensed indication, patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless they were unsuitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

The third indication for Lynparza in the EU

The approval was based on data from the randomised, open-label, Phase III OlympiAD trial which tested Lynparza vs. physician’s choice of chemotherapy (capecitabine, eribulin, or vinorelbine). In the trial, Lynparza provided patients with a statistically-significant median progression-free survival improvement of 2.8 months (7.0 months for Lynparza vs. 4.2 months for chemotherapy). Patients taking Lynparza experienced an objective response rate (ORR) of 52%, which was double the ORR for those in the chemotherapy arm (23%).

This is the third indication for Lynparza in the EU, and AstraZeneca and MSD are working together to deliver Lynparza as quickly as possible to more patients across multiple settings. Lynparza has a broad clinical development programme, including the ongoing Phase III OlympiA which is testing Lynparza as an adjuvant treatment in patients with gBRCAm HER2-negative breast cancer.

Photo of David Fredrickson: AstraZeneca

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