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The FDA has granted Fast Track designation to the investigational HER2-targeting antibody drug conjugate DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

FDA; breast cancer. ... - Click to enlarge in new windowFDA; breast cancer. FDA; breast cancer

Fast Track designation was granted based on results from the dose escalation part of a two-part phase I study that assessed the safety, tolerability, and preliminary efficacy of DS-8201. The second part (dose expansion) of the ongoing phase I study is enrolling patients in Japan and the U.S. to evaluate the safety and efficacy of DS-8201 in four different cohorts of HER2 expressing cancers: patients with HER2+ metastatic breast cancer previously treated with T-DM1; patients with HER2+ gastric or gastroesophageal junction adenocarcinoma previously treated with trastuzumab; patients with HER2 low expressing breast cancer; and patients with other solid cancers that express HER2.