WESTMINSTER, Colo.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of the Company’s Phase 3 clinical trial of FOLOTYN® (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL). The study will seek to enroll newly diagnosed patients with PTCL who have achieved a response following initial treatment with a CHOP-based therapy. The SPA provides FDA agreement that the study design and planned analysis of this Phase 3 trial adequately address the objectives necessary to support a regulatory submission.
