The Food and Drug Administration approved Pomalyst (pomalidomide) on Feb. 8 to treat patients with multiple myeloma who have progressed during or within 60 days after receiving at least two therapies, such as Revlimid (lenalidomide) or Velcade (bortezomib).
Pomalyst is a derivative of Thalomid (thalidomide), another drug used to treat multiple myeloma and in the same family of drugs as Revlimid. Called immunomodulating agents, these drugs incite the immune system to attack the myeloma cells.
The approval is based on a phase 2 clinical trial in which patients received either Pomalyst and low-dose dexemethasone, a type of steroid, or Pomalyst alone. In those on Pomalyst alone, 7.4 percent had their cancer completely or partially disappear compared with 29.2 percent for those receiving the combination. This response lasted for more than 7 months in the combination arm.
Pomalyst also performed well in a phase 3 clinical trial in which patients received either Pomalyst and low-dose dexemethasone, a type of steroid, or high-dose dexemethasone alone. Those in the Pomalyst combination arm lived 7.7 weeks longer without their disease progressing than those on the steroid alone. The median for overall survival had not yet been reached for those receiving Pomalyst when the data were presented at the American Society of Hematology annual meeting in December.
Common side effects included low white and red blood cell counts, fever and infections. The drug also includes a boxed warning (the highest warning the FDA can give) that pregnant women should not take the drug as it causes serious side effects, such as blood clots and birth defects. Therefore, prescribing physicians must be certified with the Pomalyst Risk Evaluation and Management Strategy (REMS) program.
For more information, visit pomalyst.com or call 800-931-8691.