U.S. FDA grants fast track designation for HER2-targeting antibody drug conjugate DS-8201 for HER2-positive metastatic breast cancer

Daiichi Sankyo

1 December 2016 - Novel antibody drug conjugate with proprietary payload and linker-payload technology currently in phase 1 development for the treatment of HER2-positive metastatic breast cancer for patients who progress after prior HER2-targeting therapies including T-DM1.

Daiichi Sankyo today announced that the U.S. FDA has granted fast track designation to its 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).

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder

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US , Medicare , Fast track