FDA Approves Pomalyst for Multiple Myeloma
On February 8, 2013 the U.S. Food and Drug Administration approved a new drug to treat multiple myeloma. The drug, Pomalyst (pomalidomide) is approved for use in patients whose disease has progressed after being treated with other cancer drugs.
Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow, with approximately 21,700 patients newly diagnosed 10,710 deaths yearly in the United States.
Pomalyst is available as a tablet (pill). It works by modulating the body’s immune system to destroy cancerous cells and inhibit their growth. It 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 (relapsed and refractory). Pomalyst was approved with an orphan product designation because it is intended to treat a rare disease or condition.
Pomalyst carries a Boxed Warning alerting patients and health care professionals that the drug should not be used in pregnant women because it can cause severe life-threatening birth defects, and that the drug can cause blood clots.
Pomalyst is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program, which is similar to the REMS prorams required for lenalidomide and thalidomide.
Common side effects include a decrease in infection-fighting white blood cells (neutropenia), fatigue and weakness, low red blood cell count (anemia), constipation, diarrhea, low levels of platelets in the blood (thrombocytopenia), upper respiratory tract infections, back pain and fever.
More info can be found at the FDA’s website: Link to FDA Press Release
Tags: cancer, multiple myeloma, oncology