In September 2009, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of 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. FOLOTYN has been available to patients in the U.S. since October 2009.
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma, or CTCL, is comprised of indolent non-Hodgkin T-cell lymphomas which have their primary manifestations in the skin. The most common CTCL subtypes are mycosis fungoides and Sézary syndrome. 1-2 The incidence of CTCL is increasing in the United States with approximately 3,000 new cases being diagnosed annually. CTCL affects over 30,000 in the U.S. and Canada. 3
About Allos TherapeuticsAllos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. Allos is currently focused on the development and commercialization of FOLOTYN ® (pralatrexate injection), a folate analogue metabolic inhibitor. FOLOTYN is approved in the U.S. for the treatment of patients with relapsed or refractory PTCL. For additional information, please visit www.allos.com. IMPORTANT SAFETY INFORMATION Warnings and Precautions FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities. Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B 12 to potentially reduce treatment-related hematological toxicity and mucositis. Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may occur. Monitor patients and treat if needed.