Allos Therapeutics Initiates Phase 3 Registration Trial of FOLOTYN in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma Following Treatment with a CHOP-based Regimen

Allos Therapeutics, Inc. ALTH today announced the enrollment of the first patient in a Phase 3 randomized clinical trial evaluating FOLOTYN in patients with previously undiagnosed peripheral T-cell lymphoma. This study is open to enroll newly diagnosed patients with PTCL who have achieved an objective response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or a CHOP-like regimen. Earlier this year, Allos reached agreement with the U.S. Food and Drug Administration under its Special Protocol Assessment process on the design of this Phase 3 trial. 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. FOLOTYN, a folate analogue metabolic inhibitor, is approved in the U.S. for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.