Foghorn’s AML/MDS Program Likely Still A Go Despite Partial Hold

Foghorn Therapeutics Inc.’s development program for FHD-286 has run into trouble as the US Food and Drug Administration has placed a partial clinical hold in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) following a patient death. But the drug may still be able to move forward as the death was due to a problem that has occurred with some approved AML drugs.

The company said 19 May that the FDA had placed the partial clinical hold on its dose-escalation study of FHD-286 after the death, which was due to differentiation syndrome (DS), a potentially fatal condition associated with AML/MDS drugs that induce differentiation