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AstraZeneca and MSD’s breast cancer drug Lynparza receives FDA approval

An estimated 2.3 million patients were diagnosed with breast cancer in 2020


AstraZeneca (AZ) and MSD – known as Merck & Co in the US and Canada – have announced that the companies’ jointly developed drug Lynparza (olaparib) has been approved by the US Food and Drug Administration (FDA). Lynparza is the first and only approved medicine targeting BRCA mutations in early breast cancer.

The FDA approval is specifically for the treatment of patients with BRCA-mutated HER2-negative high-risk early breast cancer who have already received chemotherapy treatment either before or after surgery.

As the most diagnosed cancer worldwide, an estimated 2.3 million patients were diagnosed with breast cancer in 2020. In the US, almost 91% of all breast cancer patients are diagnosed at an early stage of disease, with BRCA mutations found in approximately 5-10% of patients.

The FDA based its decision on results from the OlympiA phase 3 trial which were presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine.

The phase 3 trial is a double-blind, multicentre study testing the safety and effectiveness of Lynparza versus placebo. During the trial, Lynparza showed a significant improvement in survival rates, reducing the risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo.

The overall survival data is due to be presented presented at an upcoming European Society for Medical Oncology virtual plenary on 16 March 2022.

Professor Andrew Tutt, global Chair of the OlympiA phase 3 trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said: “OlympiA has shown that identifying a BRCA1/2 mutation in women with high risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients.”

Dave Fredrickson, executive vice president, Oncology Business Unit, AZ, said: “Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients’ lives versus placebo. The data underlines the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza.”

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD phase 3 trial. In the EU, this indication also includes patients with locally advanced breast cancer.

Article by
Fleur Jeffries

15th March 2022

From: Regulatory



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