FDA grants accelerated approval to Pomalyst (Celgene) to treat Multiple Myeloma

The FDA on 8 February 2013, approved Pomalyst (pomalidomide), from Celgene, to treat patients with Multiple Myeloma whose disease progressed after being treated with other cancer drugs. Pomalyst is a pill that modulates the body�s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory).

Pomalyst is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat Multiple Myeloma,In July 2012, FDA approved Kyprolis (carfilzomib) from Onyx Pharma to treat Multiple Myeloma. Pomalyst is being approved under the agency�s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug�s clinical benefit and safe use.