FDA Places Partial Clinical Hold on Foghorn’s AML and MDS Study Due to Patient Death

The FDA has placed a partial clinical hold on Cambridge, Mass.-based Foghorn Therapeutics’ early-stage dose-escalation clinical trial of FHD-286, an investigational treatment for relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).

The agency placed the partial hold because of a patient death linked to differentiation syndrome, a potential side effect in patients with acute myeloid leukemia who have been treated with certain anticancer drugs.

Until the partial clinical hold is lifted, patients currently enrolled in the study can continue to receive treatment, but no new patients can be enrolled.

The FDA has requested a review of the safety database, risk mitigation strategies and a breakdown of clinical activity across dose levels, the company said.