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FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer

Jason Harris
Published: Tuesday, Aug 29, 2017

Antoine Yver, MD

Antoine Yver, MD
The investigational HER2-targeting antibody-drug conjugate DS-8201 has received an FDA breakthrough therapy designation for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).

Daiichi Sankyo has initiated the pivotal phase II DESTINY-Breast01 study evaluating the safety and efficacy of DS-8201 in patients with HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1.
Doi T, Iwata H, Tsurutani J, et al. Single agent activity of DS-8201a, a HER2-targeting antibody-drug conjugate, in heavily pretreated HER2 expressing solid tumors. J Clin Oncol 35, 2017 (suppl; abstr 108).

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