Cellectar Introduces Breakthrough Radiotherapeutic Iopofosine I-131 for the Treatment of Waldenstrom’s Macroglobulinemia
Cellectar has introduced iopofosine I-131 as the first and only investigational radiotherapeutic agent to receive FDA Breakthrough Therapy designation for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (r/r WM).
Iopofosine I-131 is a novel cancer-targeting agent that uses a phospholipid ether radioconjugate to deliver targeted radiotherapy directly to cancer cells. This first-in-class monotherapy is designed to improve outcomes in patients with WM, a rare and currently incurable subtype of lymphoplasmacytic lymphoma.
There are limited treatment options available for WM, and current therapies do not offer a cure, highlighting a critical need for innovative treatment approaches.
The FDA’s Breakthrough Therapy designation recognises the potential of iopofosine I-131 to offer substantial improvement over existing therapies in a life-threatening condition. The therapy has also been granted Fast Track and Orphan Drug designations by the FDA, as well as Orphan Drug and PRIME designations by the European Medicines Agency (EMA).
Waldenstrom’s macroglobulinemia is a rare blood cancer marked by excessive production of abnormal white blood cells, leading to complications such as anaemia, bleeding, and neurological issues. In the Phase 2 CLOVER WaM study, iopofosine I-131 demonstrated a major response rate of 58.2% and an overall response rate of 83.6%, exceeding the primary endpoint and supporting its promise as a transformative therapy.
Iopofosine I-131 is the first and only investigational radiotherapeutic agent to receive U.S. FDA Breakthrough Therapy designation for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia.
