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

AstraZeneca (AZ) and MSD’s – known as Merck & Co in the US and Canada – Lynparza (olaparib) has been approved by the European Commission (EC) for the treatment of patients with germline BRCA-mutated HER2-negative high-risk early breast cancer, the companies announced.

The EC approval is specifically for Lynparza as a monotherapy or in combination with endocrine therapy for patients previously treated with neoadjuvant or adjuvant chemotherapy.

Breast cancer is the most diagnosed type of cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020. Approximately 90% of all breast cancer patients worldwide are diagnosed with early breast cancer and BRCA mutations are found in approximately 10% of HER2-negative patients in Europe.

The decision was based on data from the phase 3 OlympiA trial published in The New England Journal of Medicine in June 2021.

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 treatment also demonstrated improvement in overall survival, reducing the risk of death by 32% versus placebo.

Lynparza, which is being jointly developed and commercialised by AZ and MSD, is a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor and the first targeted treatment to block DNA damage response in cells and tumours harbouring a deficiency in homologous recombination repair, such as those with mutations in BRCA1 and BRCA2, or those where deficiency is induced by other agents.

Dave Fredrickson, executive vice president and head of global clinical development, AZ, said: “This important approval gives early-stage breast cancer patients in the US with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today. Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirms it also significantly extends patients’ lives versus placebo. This data underlines the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza.”

The announcement follows the US Food and Drug Administration’s (FDA) approval of Lynparza in March 2022 for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.