AstraZeneca and Merck & Co said Monday that their breast cancer drug received regulatory approval in Japan for use in patients with recurrent breast cancer who have previously had chemotherapy. This comes as a clinical trial showed that breast cancer treatment Lynparza significantly prolonged progression-free survival compared with chemotherapy, reducing the risk of disease progression or death by 42%. This was the second approval of Lynparza in Japan, following an earlier approval as maintenance treatment for women with ovarian cancer. ‘Earlier this year, Lynparza became the first PARP inhibitor available in Japan for advanced ovarian cancer. Now patients in Japan with BRCA-mutated, metastatic breast cancer will also have the opportunity to benefit from Lynparza,’ Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca. ‘This approval is significant for breast cancer patients as the evaluation of BRCA mutations, in addition to hormone receptor and HER2 status, now becomes an important step in the management of the disease,’ said Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories.
