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# FDA Breakthrough Status for GlycoMimetics Leukemia Drug
- URL: https://www.fdaweb.com/fda-breakthrough-status-for-glycomimetics-leukemia-drug/
- Published: 2017-05-19T12:00:00.000Z
- Updated: 2026-09-14T22:24:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138737

FDA has granted a breakthrough therapy designation to GlycoMimetics for GMI-1271 and its use in treating adult relapsed/refractory acute myeloid leukemia (AML). The E-selectin antagonist is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. FDA previously granted the therapy an[ orphan drug designation and fast track status.](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fir.glycomimetics.com%2Freleasedetail.cfm%3Freleaseid%3D913253&esheet=51561328&newsitemid=20170517006262&lan=en-US&anchor=The+U.S.+Food+and+Drug+Administration%C2%A0%28FDA%29+had+previously+granted+Orphan+Drug+designation+and+Fast+Track+Status+for+GMI-1271+in+AML&index=1&md5=4f0054be3a813f31192a4366e350b262&ref=fdaweb.com) According to GlycoMimetics, data from the ongoing clinical trial showed that patients treated with GMI-1271 achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML as well as in newly diagnosed patients.