Iopofosine I 131 receives PRIME designation from the EMA for patients with Waldenstrom's macroglobulinemia

Waldenstrom’s macroglobulinemia (WM) is a unique and rare type of non-Hodgkin lymphoma. There is an unmet need for novel treatment approaches for patients with WM who experience relapse after ≥2 prior treatment regimens. Iopofosine I 131 (I-131), a small-molecule phospholipid drug conjugate, provides targeted delivery of I-131 directly into the cancer cells and spares normal tissues. It has been selected by the European Medicines Agency (EMA) for Priority Medicines (PRIME) designation and will be investigated in CLOVER-WaM (NCT02952508), a phase IIb pivotal trial, for efficacy and safety in patients with WM after ≥2 prior treatment regimens. Topline data is expected to be released in the final quarter of 2023.

I-131 previously received Fast Track designation from the FDA for patients with lymphoplasmacytic lymphoma or Waldenström’s macroglobulinemia who had previously received ≥2 therapies, patients with relapsed or unresponsive multiple myeloma, and patients with unresponsive refractory diffuse large B-cell lymphoma.

The FDA also granted Fast Track Designation to I-131, which is expected to advance its approval in 2024 in the United States.

‘The International Waldenstrom's Macroglobulinemia Foundation (IWMF) and the Lymphoma Hub are working in collaboration for patients with Waldenstrom's macroglobulinemia. This initiative aims to increase awareness of Waldenstrom's macroglobulinemia among healthcare professionals, patients, caregivers, and the patient advocacy community. 

This initiative is funded by Beigene and Cellectar Biosciences. All content is developed independently by SES in collaboration with an expert steering committee; funders are allowed no direct influence on the content of the hub.’