Daiichi Sankyo Launches ENHERTU in Japan for Patients with HER2 Positive Unresectable or Metastatic Breast Cancer
Tokyo, Munich: Daiichi Sankyo Company, Limited has announced the launch of ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), 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).
Marketing approval of ENHERTU by Japan's Ministry of Health, Labor, and Welfare (MHLW) in March 2020 was based on the results of the open-label, single-arm, pivotal phase 2 DESTINY-Breast01 trial that demonstrated a confirmed objective response rate of 64.1% [95% CI: 56.3-71.3] in the response evaluable set of 107 of 167 patients, which included 26 Japanese women, at a data cut-off of March 21, 2019. Data from the DESTINY-Breast01 trial were published in The New England Journal of Medicine.
"Now patients in Japan with HER2 positive metastatic breast cancer who progress following treatment with at least two HER2 directed therapies and chemotherapy have access to ENHERTU, an important new medicine that may transform the way these patients are treated. We are proud of how quickly we have delivered ENHERTU, making it available only four years after treating the first patient in Japan," said Hideaki Noji, Vice President, Head of Specialty Marketing in Japan, Daiichi Sankyo. "ENHERTU also represents the second innovative oncology medicine to be launched in Japan from the oncology pipeline of Daiichi Sankyo in the past year, another milestone we are honored to have achieved."
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