First and only approved medicine in US targeting BRCA mutations in early breast cancer

LYNPARZA® (olaparib) has been approved in the US 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.

The FDA approval was based on results from the OlympiA Phase III trial presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. In the trial, the treatment demonstrated significant improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, second cancers or death, by 42% versus placebo.

“Today’s approval of olaparib is great news for patients with a specific inherited form of breast cancer,” said Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London. “Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high and new treatment options are needed. 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.”

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

LYNPARZA is now indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for LYNPARZA.

Ana Ovey