Allos Therapeutics, Inc. (ALTH) Announces Outcome of Request for Re-examination of CHMP Opinion for FOLOTYN® in Europe
4/20/2012 9:58:39 AM
WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (NASDAQ: ALTH) announced today that following its request for re-examination, the European Medicines Agency’s Committee For Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the marketing authorisation application (MAA) for FOLOTYN® (pralatrexate injection) as a treatment for patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy. Allos intends to review the CHMP opinion and evaluate its potential options for continuing to pursue regulatory approval of FOLOTYN in Europe for this indication.
comments powered by