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AstraZeneca: EU Spproves Lynparza As Monotherapy For Germline BRCA1/2-mutations

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

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 or HR-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

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. Patients taking Lynparza experienced an objective response rate of 52%, which was double the ORR for those in the chemotherapy arm.

This is the third indication for Lynparza in the EU, and AstraZeneca and Merck 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.

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