Pomalidomide Approved for Refractory Myeloma

Pomalidomide has been accelerated approved by US FDA for multiple myeloma that has progressed on at least two previous therapies including bortezomib and lenalidomide, within 60 days of the last therapy. The approval was based on the multicenter, randomized, open-label study CC-4047-MM-002. The approval is based on response rates. Pomelidomide has not been as yet shown to improve survival. The combination of pomalidomide and low dose dexamethasone was resulted in a 29% response in 113 patients with one complete response and a median duration of response of 7.4 months.