Lynparza (olparib), the poly ADP ribose polymerase (PARP) inhibitor developed by AstraZeneca and MSD, has been awarded marketing approval by the European Commission, it has emerged, as a monotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer with germline BRCA1/2-mutations (gBRCAm).

Phase 3 data submitted in support of the application demonstrated that Lynparza improved median progression-free survival by 2.8 months and doubled objective response rates to 52% from 23% compared to physician’s choice of chemotherapy: either capecitabine, eribulin, or vinorelbine.

The new indication stipulates that, where suitable, potential patients should have already received an anthracycline and a taxane in the (neo)adjuvant or metastatic setting, while hormone receptor (HR)-positive breast cancer patients should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

"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," commented Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at 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."

Dave Fredrickson, Executive Vice President, Oncology, also 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."

by Matt Fellows

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