Pomalyst pomalidomide regulatory update

FDA approved an updated label for Pomalyst pomalidomide from Celgene to include progression-free survival (PFS) and overall survival (OS) benefits for patients with refractory multiple myeloma (MM). Celgene said it fulfilled FDA’s accelerated approval requirements based on data from the Phase III MM-003 trial. Pomalyst is approved in the U.S. to treat MM in combination with dexamethasone in patients who have received at least 2 prior therapies, including Revlimid lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy (see BioCentury, Feb. 11, 2013). ...