AstraZeneca and Merck, known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the adjuvant treatment for patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high recurrent risk breast cancer.

This approval was based on results from the Phase 3 OlympiA trial published in The New England Journal of Medicine in June 2021. In the trial, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42%.

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, “Today’s approval marks a new era of care for patients in Japan. For patients with high-risk early-stage breast cancer, including those with germline BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and systemic treatment. Today’s approval offers eligible patients in Japan an effective and targeted treatment that improves survival and helps to prevent cancer recurrence.”

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “Today’s approval marks a significant leap forward for breast cancer patients in Japan, where it is the most commonly diagnosed cancer among women. Patients with BRCA mutations have high rates of disease recurrence and lower survival, and LYNPARZAhas been shown to significantly reduce both the risk of recurrence and death. We hope this approval sets a new, much-needed standard of care for these early breast cancer patients in Japan.”

Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “With this approval, LYNPARZA becomes the first and only PARP inhibitor available for patients with BRCA-mutated, HER2-negative early breast cancer in Japan. This further reinforces the critical need to conduct BRCA testing at the point of diagnosis so that all eligible patients can be identified.”

In March 2022, LYNPARZAwas approved in the U.S. for the adjuvant treatment of patients with germline BRCAm (gBRCAm), HER2-negative high-risk early breast cancer, followed by approval in the European Union (EU) in August 2022, based on results from the OlympiA trial. LYNPARZA is also approved in the U.S., EU, Japan and several other countries for the treatment of adult patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy and, if hormone receptor-positive, endocrine therapy if appropriate based on results from the Phase 3 OlympiAD trial. In the EU, this indication also includes patients with locally advanced breast cancer.