FDA Approves Drug for Relapsed, Refractory Multiple Myeloma


The U.S. Food and Drug Administration has announced the approval of the drug Pomalyst (pomalidomide) for the treatment of patients with relapsed and refractory multiple myeloma, whose disease has progressed after two prior treatments.

Multiple myeloma is a blood cancer that primarily affects older adults. It arises from plasma cells in the bone marrow, and around 21,700 Americans are newly diagnosed with the disease annually.

This new drug, approved under the accelerated approval program, is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.

Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research:

"Pomalyst is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma. Treatment for multiple myeloma is tailored to meet individual patient’s needs, and today’s approval provides an additional treatment option for patients who have not responded to other drugs."

Pomalyst is taken orally. It modulates the body’s immune system to destroy cancerous cells and inhibit their growth.

Source: FDA

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