Japanese regulators have granted a Sakigake designation to trastuzumab deruxtecan (DS-8201), for the treatment of patients with HER2-positive gastric cancer that is refractory to trastuzumab (Herceptin), according to Daiichi Sankyo, the manufacturer of the antibody-drug conjugate.
In August 2017, the FDA granted trastuzumab deruxtecan a breakthrough therapy designation for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).
Iwasa S, Shitara K, Takahashi S, et al. Updated results of phase 1 study of DS-8201a in subjects with HER2-expressing gastric cancer. Presented at: 2018 Gastrointestinal Cancers Symposium; January 18-20, 2018; San Francisco, Calif. Abstract 118.
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