The US Food and Drug Administration (FDA) has granted accelerated approval for pralatrexate injection (Folotyn) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), which comprises a biologically diverse group of aggressive blood cancers. Pralatrexate 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. On October 5, Allos Therapeutics announced that the drug has been made available to patients in the United States.
“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,” said Owen A. O’Connor, MD, PhD, principal investigator in the PROPEL study; and chief, Division of Hematologic Malignancies and Medical Oncology; and professor of medicine and pharmacology at the NYU Langone Medical Center.
The New Drug Application (NDA) submitted for pralatrexate was based on data from the PROPEL trial. Allos reports that PROPEL is the largest prospective, multicenter, international trial ever conducted in patients with relapsed or refractory PTCL. “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.”
Patient Assistance Program
Allos 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 a hotline at 1-877-ASAP102 (272-7102). In connection with the accelerated approval, Allos has agreed to undertake additional clinical studies to further verify and describe the clinical benefit of pralatrexate in patients with T-cell lymphoma.