European Commission Approves Celgene's Multiple Myeloma Treatment


Celgene, maker of the oral medication pomalidomide, has received market approval from the European Commission for pomalidomide in combination with dexamethasone (a steroid) for the treatment of relapsed and refractory multiple myeloma in patients who have received previous therapies.

Approval arrived on the heels of results from a Phase III trial of 455 patients who experienced prolonged survival after being treated with pomalidomide plus low-dose dexamethasone.

In multiple myeloma, plasma cells grow out of control and build up in the bone marrow.

A new name

The U.S. Food and Drug Administration approved the drug in February under the name Pomalyst. However, Celgene intends to market the drug under the name Imnovid in Europe.

Imnovid will not be Celgene's first drug for multiple myeloma, as the biopharmaceutical company also manufactures Revlimid (lenalidomide).

Source: FierceBiotech

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