Pomalyst pomalidomide regulatory update

Celgene said Health Canada approved Pomalyst pomalidomide in combination with dexamethasone to treat patients with multiple myeloma (MM). Specifically, Pomalyst is indicated in adults for whom both Velcade bortezomib and Celgene's Revlimid lenalidomide have failed, who have received >=2 prior therapies and whose disease progressed while on their last therapy. Celgene expects to launch the drug in March.

The European Commission approved the analog of thalidomide as Imnovid in August, and FDA granted accelerated approval to the product as Pomalyst in February 2013 (see BioCentury, Feb. 11, 2013 & Aug. 12, 2013). Pomalidomide is in Phase III testing for myelofibrosis and systemic sclerosis, for which it has Orphan Drug designation in the EU. ...