Allos Therapeutics, Inc. (ALTH)' Marketing Authorisation Application (MAA) for FOLOTYN(R) Accepted for Review by European Medicines Evaluation Agency
12/21/2010 9:33:09 AM
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the Company’s Marketing Authorisation Application (MAA), seeking approval of FOLOTYN® (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), has been accepted by the European Medicines Agency (EMA). Acceptance of the MAA by the EMA indicates that the application is complete and initiates the EMA’s regulatory review process. The MAA is based on clinical data from the Company’s pivotal Phase 2 trial known as PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral T-cell Lymphoma).