Pomalyst (pomalidomide) is approved under the FDA’s accelerated approval program
For those patients with multiple myeloma whose disease has progressed after being treated with other cancer drugs, the FDA has recently approved a new drug, Pomalyst (pomalidomide).
Pomalidomide guides the body’s immune system in an effort to destroy cancerous cells and inhibit their growth. It is a pill intended for patients who have received at least 2 prior therapies, including lenalidomide and bortezomib. Pomalidomide is a treatment option for those whose disease did not respond to treatment and progressed within 60 days of the last treatment.
“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, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Treatment for multiple myeloma is tailored to meet individual patient’s needs, and [this] approval provides an additional treatment option for patients who have not responded to other drugs.”
Pomalidomide’s safety and effectiveness was evaluated in a clinical trial designed to measure objective response rate (ORR). The trial included 221 patients with relapsed or refractory multiple myeloma who were randomly assigned to receive pomalidomide alone or pomalidomide with low-dose dexamethasone.
Although the median duration of response has not yet been reached in the patients treated with pomalidomide alone, study results showed a 7.4% ORR for this group. For the patients treated with pomalidomide plus low-dose dexamethasone, 29.2% achieved ORR with a 7.4-month median duration of response.
Because it can cause blood clots and severe life-threatening birth defects, pomalidomide should not be used in pregnant women. Therefore, pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must also be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements.
Common side effects include anemia, back pain, constipation, diarrhea, fatigue and weakness, fever, neutropenia, thrombocytopenia, and upper respiratory tract infections.
Source: FDA.