FDA Drug To Treat Multiple Myeloma In Select Patients Only

By Hilda Scott email: , Feb 25, 2013 12:48 PM EST

This month the U.S. Food and Drug Administration approved Pomalyst, a new drug treatment for advanced multiple myeloma. Multiple myeloma is a rare type of blood cancer that affects approximately 21,700 Americans, according to the National Cancer Institute.

The new FDA-approved drug will treat patients who have had progression of the disease after cancer treatment. Across the nation, 10,710 die annually from multiple myeloma, a bone marrow disease that affects mostly older adults.

Good Morning America's anchorwoman Robin Roberts announced last year that she was suffering from the disease and took time off to undergo a bone marrow transplant. Roberts returned to her anchor chair on Feb. 20, after months of recovering.

Pomalyst balances the body's immune system to destroy cancerous cells and stop them from growing.

"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, "said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation. "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," said Pazdur.

Kyprolis was introduced in July 2012 to treat multiple myeloma and was approved under the FDA's accelerated approval program. Pomalyst is being approved in the same manner, to provide patients with earlier access to the drug. A clinical trial of 221 patients with relapsed or stubborn cases of multiple myeloma was conducted to evaluate Pomalyst's safety and effectiveness. As per the FDA's news release, "The trial was designed to measure the number of patients whose cancer completely or partially disappeared after treatment (objective response rate, or ORR)."

Data from the trial showed that 7.4 percent of patients treated with only Pomalyst achieved ORR. In patients that received Pomalyst along with low doses of a drug used to treat inflammatory and autoimmune conditions, dexamethasone, a total of 29.2 percent ORR was achieved.

A box warning for Pomalyst alerts patients and health care professionals that it may cause life-threatening birth defects and should not be used by pregnant women. The drug can also cause blood clots and other common side effects are a decrease in infection-fighting white blood cells, fatigue and weakness, anemia, constipation, diarrhea, low levels of platelets in the blood, upper respiratory tract infections, back pain and fever.

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