FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN^TM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos expects to make FOLOTYN available to patients in the U.S. in October.

“Individuals with peripheral T-cell lymphoma have a very poor prognosis and almost always relapse or become refractory to initial therapy. As a result, there is an urgent need for new therapies to treat patients with this challenging disease. FOLOTYN has demonstrated its efficacy and safety in the PROPEL clinical trial, and I believe it will be a welcome addition for physicians who treat patients with relapsed or refractory PTCL,” stated Owen A. O'Connor, MD, PhD, principal investigator in the PROPEL study of FOLOTYN; deputy director for Clinical Research and Cancer Treatment, NYU Cancer Institute; chief, Division of Hematologic Malignancies and Medical Oncology; professor of Medicine and Pharmacology at the NYU Langone Medical Center.

PTCL comprises a biologically diverse group of aggressive blood cancers that has a poor prognosis. The Company’s New Drug Application (NDA) for FOLOTYN was based on data from the PROPEL trial. The Company believes PROPEL is the largest prospective, multicenter, international trial ever conducted in patients with relapsed or refractory PTCL.

“We are enthusiastic about providing this new therapy to patients with relapsed or refractory PTCL,” said Paul L. Berns, president and chief executive officer at Allos Therapeutics, Inc. “The approval of FOLOTYN is a transformative event for Allos representing our first U.S. indication. We thank the many patients and clinical investigators who participated in the PROPEL study. Moving forward, we plan to continue advancing the FOLOTYN clinical development program.”

“Aggressive peripheral T-cell lymphomas have been a largely ignored group of diseases,” said James O. Armitage, MD, The Joe Shapiro Professor of Medicine, Department of Internal Medicine, University of Nebraska Medical Center. “It is exciting to have the first FDA-approved therapy for relapsed or refractory peripheral T-cell lymphoma.”