Cellectar Biosciences, Inc. announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to iopofosine I 131, the company's lead small-molecule drug candidate, for Waldenstrom's macroglobulinemia (WM) in patients who have received two or more prior treatment regimens. The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. These medicines are considered priority medicines by the EMA and are intended to reach patients earlier.

To be accepted for PRIME, new therapies must demonstrate the potential to significantly address an unmet medical need in clinical trials. The U.S. Food and Drug Administration (FDA) has granted Cellectar's lead asset iopofosine I 131, a small-molecule Phospholipid Drug Conjugate(TM) (PDC) designed to provide targeted delivery of iodine-131 (radioisotope), Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as relapsed (or refractory) multiple myeloma and relapsed (or refractory) diffuse large B-cell lymphoma (DLBCL). The company expects to complete ongoing Phase 2b WM pivotal trial (NCT02952508) in the second half of 2023 and assuming an FDA Priority Review and approval, remains on target for a 2024 US product launch.