On 24th May 2017, the European Medicines Agency’s (EMAs) Committee for Orphan Medicinal Products (COMP) granted Orphan Drug Designation for actimab-A for the treatment of patients with newly diagnosed Acute Myeloid Leukemia (AML).1
Actimab-A, an Antibody-Drug Conjugate (ADC), consists of the CD33-targeting monoclonal antibody lintuzumab and the alpha-emitting radioisotope actinium-225. Actimab-A targets CD33, (expressed on majority of AML cells) via the antibody lintuzumab and delivers powerful actinium-225, which kills the AML cells. Actinium-225 releases high-energy alpha particles as it decays, which kills cancer cells.2
Actimab-A is currently being explored in combination with Low Dose cytosine arabinoside (LDAC) in a phase 2 study (NCT02575963) for previously untreated elderly AML patients who are above the age of 60 and are ineligible for standard induction therapy.