Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that FOLOTYN™ (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. For full prescribing information for FOLOTYN, visit www.folotyn.com. FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new therapeutic option for patients with relapsed or refractory PTCL.
Allos plans to market and sell FOLOTYN in the U.S. through its commercial organization, which includes 25 sales specialists and will be increased to approximately 50 in advance of the Company’s planned full-scale commercial launch in January 2010. FOLOTYN is now available to U.S. health care providers through their normal ordering process.