Daiichi Sankyo files for DS-8201 approval in Japan for HER2 positive metastatic breast cancer

9 September 2019

Japan’s Daiichi Sankyo (TYO: 4568) saw its shares rise 2.6% to 7,230 yen today, after saying it had submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer.

The Japan NDA is primarily based on the positive results from the pivotal Phase II DESTINY-Breast01 trial of [fam-] trastuzumab deruxtecan, an open-label, global, multicenter trial, which evaluated dosing, efficacy and safety in patients with HER2 positive metastatic breast cancer. The drug is under development with Anglo-Swedish pharma major AstraZeneca (LSE: AZN).

The submission also includes data from the Phase I trial published in The Lancet Oncology. The response rate observed in DESTINY-Breast01, as assessed by an independent review committee, confirmed the clinical activity observed in the Phase I trial.

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