Daiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).
DS-8201 [fam-] trastuzumab deruxtecan), is an investigational antibody-drug conjugate (ADC) designed to deliver cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.
Japan’s NDA is based on the results of DESTINY-Breast01, a global pivotal phase II study.
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