Allos' FOLOTYN Approved By FDA - Drug Discovery and Development

Allos Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN (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.1 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.2 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.”

Allos is dedicated to patient access and has established a patient assistance program named ASAP (Allos Support for Assisting Patients) to provide reimbursement support. Commencing in October, more information regarding ASAP will be available by calling the Hotline at 1-877-ASAP102 (272-7102), Monday to Friday, 8 a.m. to 7 p.m. Central Time or by visiting www.getASAPinfo.com.

“The approval of FOLOTYN brings a new treatment option to patients afflicted with peripheral T-cell lymphoma,” said Peter L. Saltonstall, president and chief executive officer of the National Organization for Rare Disorders (NORD). “We at NORD are excited about this approval and will continue our efforts to focus national attention on rare diseases and on the fact that most rare diseases have no FDA-approved treatment at this time.”

In connection with the accelerated approval, Allos has agreed to undertake additional clinical studies to further verify and describe the clinical benefit of FOLOTYN in patients with T-cell lymphoma.

FOLOTYN was discovered by Sloan-Kettering Institute for Cancer Research, SRI International, and Southern Research Institute and developed by Allos Therapeutics.