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Gilead’s Magrolimab Grabs Breakthrough Therapy Designation for Myelodysplastic Syndrome

September 16, 2020

The FDA has granted a Breakthrough Therapy designation to Gilead Sciences’ investigational monoclonal antibody, magrolimab, for the treatment of newly diagnosed myelodysplastic syndrome (MDS), a group of cancers linked to abnormal blood cells.

The designation was based on the results of a phase 1b trial, in which 91 percent of patients treated with magrolimab plus azacitidine achieved a response, and 42 percent achieved a complete remission.

The agency previously granted magrolimab Fast Track and Orphan Drug designations for the treatment of MDS.

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