Posted by Michael Wonder on 25 Mar 2020
Enhertu approved in Japan for treatment of patients with HER2 positive unresectable or metastatic breast cancer
25 March 2020 - Approval based on the pivotal DESTINY-Breast01 trial represents third approval ever under the conditional early approval system in Japan, and follows recent U.S. accelerated approval of Enhertu.
Daiichi Sankyo today announced the approval of Enhertu (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate, in Japan for the treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments).
Approval of Enhertu by Japan’s Ministry of Health, Labor, and Welfare is based on the results of the open-label, single-arm, pivotal phase 2 DESTINY-Breast01 trial of Enhertu (5.4 mg/kg) monotherapy in 184 female patients (including 30 Japanese women) with HER2 positive metastatic breast cancer.
