Celgene announced that the FDA has approved Pomalyst (pomalidomide) for the treatment of patients with relapsed and/or refractory multiple myeloma. Specifically, it is intended for patients who have received at least two prior therapies, including lenalidomide (Revlimid; Celgene) and bortezomib (Velcade; Millennium), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Pomalyst is an immunomodulator that inhibits proliferation and induces apoptosis of hematopoietic tumor cell.

The approval was based on a Phase 2 study “MM-002” 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. Results showed 7.4% of patients treated with Pomalyst alone achieved ORR. In patients treated with Pomalyst plus low-dose dexamethasone, 29.2% achieved ORR with a 7.4-month median duration of response.

Because of embryo-fetal risk, Pomalyst 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 its requirements.

Pomalyst will be available in 1mg, 2mg, 3mg, and 4mg strength capsules in 21- and 100-count bottles. Pomalyst is expected to be available in about two weeks.

For more information call (800) 890-4619 or visit www.pomalyst.com