(ChemotherapyAdvisor) – Celgene has submitted a New Drug Application to the US Food and Drug Administration (FDA) for the approval of pomalidomide, which is being developed for use in patients with relapsed and refractory multiple myeloma. According to the International Myeloma Foundation, no new agents have been approved for multiple myeloma in nearly 6 years.
Pomalidomide (CC-4047), an oral immunomodulatory small molecule compound, is a derivative of thalidomide. Celgene’s other proprietary IMiDs are lenalidomide, CC-11006, and CC-10015.
A study of pomalidomide presented during the American Society of Hematology 2011 Annual Meeting found that pomalidomide 2mg/day or 4mg/day demonstrated excellent activity in patients who were refractory to thalidomide, lenalidomide, and bortezomib. Neutropenia was the primary hematologic toxicity and fatigue and pneumonia were the primary nonhematologic toxicities.
Pomalidomide is also being investigated in a Phase 3 study in myelofibrosis; data are anticipated by the end of 2012.
The proteasome inhibitor carfilzomib, being developed by Onyx Pharmaceuticals, is also undergoing FDA review for the treatment of multiple myeloma.