Cellectar announces U.S. FDA granted BTD for iopofosine I 131

Cellectar Biosciences (CLRB) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia, r/r WM. Data from the Phase 2 CLOVER WaM study, including the overall response rate of 83.6% and a major response rate of 58.2%, which exceeded the agreed-upon primary endpoint of a 20% MRR, were presented as a podium presentation during the 66th Annual American Society of Hematology Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic. Separately, the company announced that it has provided the European Medicines Agency with a data package that includes extensive supportive preclinical, regulatory and manufacturing data, as well as safety and efficacy data from the CLOVER WaM Phase 2b clinical trial.