FDA Approves Lynparza for Early Breast Cancer

The FDA has approved Merck’s Lynparza (olaparib) for the treatment of adult patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer after surgery or prior chemotherapy.

The approval was based on results from the phase 3 OlympiA trial, including data for the trial’s primary endpoint of invasive disease-free survival, which were presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine, as well as overall survival data from a more recent interim analysis.

In the OlympiA trial, Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo. Updated results from the OlympiA trial showed Lynparza reduced the risk of death by 32% versus placebo. The updated overall survival data will be presented at an upcoming European Society for Medical Oncology Virtual Plenary on March 16, 2022.

Andrew Tutt

“This approval of olaparib is great news for patients with a specific inherited form of breast cancer. 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 high, and new treatment options are needed,” Professor Andrew Tutt, global chair of the OlympiA trial and professor of oncology, The Institute of Cancer Research, London, and King’s College London, said in a press release.

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 U.S. are diagnosed at an early stage of disease, and germline BRCA mutations are found in about 5% to 10% of all breast cancer patients.

Lynparza is approved in the United States, the European Union, Japan and several other countries for the treatment of adult patients with gBRCAm, HER2-negative metastatic breast cancer previously treated with chemotherapy.