Pomalyst Approved for Advanced Multiple Myeloma

New Drugs , News / October 2, 2016

The FDA approved Pomalyst (pomalidomide) for the treatment of multiple myeloma patients whose disease 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. Pomalyst is the third drug in a class of immunomodulatory agents that include lenalidomide and thalidomide; it is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patietns who have received at least two prior therapies, including lenalidomide (Revlimid) and bortezomib (Velcade), and whose disease showed no response to treatment and progressed within 60 days of the last treatment (relapsed and refractory).

Pomalyst’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory 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 Pomalyst alone or Pomalyst with low-dose dexamethasone, a corticosteroid.

Results showed 7.4% of patients treated with Pomalyst alone achieved ORR. The median duration of response has not yet been reached in these patients. In patients treated with Pomalyst plus low-dose dexamethasone, 29.2% achieved ORR with a 7.4-month median duration of response.

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.

Because of Pomalyst’s embryo-fetal risk, it 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. Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients who are not pregnant but can become pregnant must comply with the pregnancy testing and contraception requirements, and males must comply with contraception requirements. Pharmacies must 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. Both lenalidomide and thalidomide have similar REMS.

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.

Pomalyst, lenalidomide and thalidomide are marketed by Celgene, based in Summit, N.J. Kyprolis is marketed by South San Francisco, Calif.-based Onyx Pharmaceuticals.

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