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# FDA OKs Phase 1 Biomea IND Leukemia Trial
- URL: https://www.fdaweb.com/fda-oks-phase-1-biomea-ind-leukemia-trial/
- Published: 2021-09-16T12:00:00.000Z
- Updated: 2026-09-14T17:14:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150161

FDA has cleared a Biomea Fusion IND to begin a Phase 1 trial of BMF-219, a selective irreversible menin inhibitor, in adults with relapsed or refractory acute leukemia, including those with an MLL/KM2TA gene rearrangement or an NPM1 mutation. The company [says](https://finance.yahoo.com/news/biomea-fusion-announces-fda-clearance-173500304.html?ref=fdaweb.com) BMF-219 is a synthetic compound that forms a permanent bond to its target protein and offers potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

The Phase 1 trial will assess the safety, pharmacokinetic, and pharmacodynamic profile of the drug in adults with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or an NPM1 mutation.