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Daiichi Sankyo Co Ltd on Wednesday its metastatic breast cancer treatment with AstraZeneca PLC was approved in China as a monotherapy for adult patients. The two pharmaceutical firms jointly developed and commercialised the Enhertu treatment, which is a HER2-directed antibody drug conjugate. Tokyo-based Daiichi said the approval from China’s National Medical Products Administration is based on the results of the Destiny-Breast04 phase 3 trial. AstraZeneca is based in Cambridge, England. The approval was specifically for patients with HER2 low metastatic breast cancer, who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, Daiichi said. It follows the NMPA approval in February for Enhertu in patients with previously treated unresectable or metastatic HER2 positive breast cancer. ‘Enhertu now has the potential to become a new standard of care treatment option in China for a broad range of patients with HER2 expressing metastatic breast cancer,’ said Kiminori Nagao, head of the Asia, South & Central America business unit at Daiichi. AstraZeneca’s Executive Vice President for Oncology Dave Frederickson added: ‘Patients with HR positive or HR negative, HER2 low metastatic breast cancer previously had few effective treatment options beyond chemotherapy. The results from the Destiny-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2 low via routine testing. ‘This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide.’ In China, breast cancer is the most common cancer in women, Daiichi said, with more than 415,000 cases diagnosed in 2020 and around 18% of global breast cancer deaths with nearly 120,000. Daiichi also noted around half of all breast cancers are considered HER2 low. Shares in Daiichi closed down 2.1% to JP¥3,790.00 each in Tokyo on Wednesday, while in London, AstraZeneca shares were up 0.8% to 10,168.00 pence each at midday. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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