www.fdanews.com/articles/181894-glycomimetics-leukemia-drug-wins-fda-breakthrough-therapy-designation
GlycoMimetics’ Leukemia Drug Wins FDA Breakthrough Therapy Designation
May 23, 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.