AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of LYNPARZA tablets, as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (BRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Dave Fredrickson, executive vice president, oncology, AstraZeneca, said:
Despite progress in treating patients with advanced breast cancer, there remains a significant unmet need for new treatment options. If approved, LYNPARZA will provide these patients with both a targeted and oral chemotherapy-free option.
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said:
The positive opinion from CHMP for LYNPARZA in this patient population is an important milestone. This decision brings us one step closer to offering a new treatment option to patients with advanced breast cancer and further underscores the critical need to identify patients’ BRCA status, in addition to hormone receptor and HER2 expression status, as part of the management of this disease.
The positive opinion is based on data from the randomized, open-label, Phase 3 OlympiAD trial, which tested LYNPARZA against the physician’s choice of chemotherapy.
LYNPARZA is currently approved in over 60 countries, including those in the European Union, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the U.S. for first-line maintenance therapy in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in several countries, including the U.S. and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy – regulatory reviews are underway in other jurisdictions.