FDAnews Drug Daily Bulletin

GlycoMimetics’ Leukemia Drug Wins FDA Breakthrough Therapy Designation

May 24, 2017

GlycoMimetics received a Breakthrough Therapy designation for GMI-1271, a treatment for adult relapsed/refractory acute myeloid leukemia.

The FDA previously granted an Orphan Drug designation and Fast Track status for GMI-1271 in AML. The drug is an E-selectin antagonist currently being evaluated in the Phase II portion of a Phase I/II clinical trial in patients with AML.

In the trial, patients treated with GMI-1271 achieved higher rates of remission and lower 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory disease, as well as newly diagnosed patients.

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