EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment

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Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

On Sept. 18, 2023, Cellectar Biosciences announced that its treatment for Waldenstrom’s macroglobulinemia, Iopofosine, had been granted Priority Medicine (PRIME) status by the European Medicines Agency (EMA). Iopofosine is the company’s lead small-molecule drug candidate, meant to treat Waldenstrom’s macroglobulinemia (WM) in patients who have completed two or more prior treatment regimens. It is created to give targeted delivery of idodine-131 directly to cancer cells, limiting the exposure to healthy cells.

Waldenstrom’s macroglobulinemia is a cancer of the lymphatic system, or lymphoma, which is rare and incurable. It occurs in a B-lymphocyte or B-cell, a type of white blood cell that normally grows into a plasma cell to manufacture antibodies that help fight infections. In WM, a hostile change to the B-cell occurs during the late stages of maturing, causing the cell to multiple into a clone of identical cells. These cells are primarily in the bone marrow, but they also inhabit the lymph nodes and other tissues and organs of the lymphatic system. They produce an abundance of antibodies that build up in the body, causing a variety of issues.


Iopofosine previously received Fast Track designation in the United States from FDA for WM patients who have received two or more previous treatment regimens, as well as relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma. EMA has previously granted an Orphan Drug Disease Designation for relapsed/refractory multiple myeloma and Waldenstrom’s macroglobulinemia.

Source: Cellectar