Pomalyst is an oral medication that helps the body’s immune system battle and destroy cancer cells and block their growth.
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Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said, “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 was approved under the FDA accelerated approval program, which makes promising new drugs available to patients while the company conducts additional studies to confirm the drug’s clinical benefit and safe use. The medicine was also granted orphan product designation because it is intended to treat a rare disease or condition.
The approval of Pomalyst is based on a clinical trial involving 221 patients with relapsed (has returned) multiple myeloma. The trial was designed to measure the number of patients whose cancer completely or partially disappeared after treatment (objective response rate, or ORR). Patients were randomly assigned to receive either Pomalyst alone or Pomalyst with low-dose dexamethasone, a corticosteroid.
The study found that 7.4 percent of patients treated with Pomalyst alone achieved ORR. The median response time has not yet been reached in these patients. Of the patients who received Pomalyst plus low-dose dexamethasone, 29.2 percent achieved ORR, which lasted a median of 7.4 months.
Pomalyst carries a Boxed Warning alerting patients and healthcare professionals that the drug should not be given to women who are pregnant because it can cause life-threatening birth defects. It also warns that the drug can cause blood clots.
As a result of the embryo-fetal risk, Pomalyst will be available only through the Risk Evaluation and Mitigation Strategy (REMS), which outlines special requirements for both the prescribing physician and patient.
Common side effects of Pomalyst 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.
Pomalyst is marketed by Celgene, based in Summit, NJ.