Annamycin granted Orphan Drug Designation by the EMA

On April 18, 2024, the European Medicines Agency granted Orphan Drug Designation to annamycin, a next-generation, non-cardiotoxic, anthracycline, for the treatment of patients with acute myeloid leukemia.¹ Annamycin was previously granted Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with relapsed/refractory acute myeloid leukemia.¹

The safety and efficacy of annamycin in combination with cytarabine is currently being investigated in the ongoing phase I/II MB-106 trial (NCT05319587).¹ Preliminary findings from this trial include a composite complete remission rate of 60% when this combination is used in patients who received one prior line of therapy (n = 10), and an overall interim composite complete remission rate of 39% in all patients regardless of the number of lines of prior therapies (n = 18).¹