Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in January by the EMA’s Committee For Medicinal Products for Human Use (CHMP) for conditional approval of FOLOTYN
(pralatrexate injection) for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy. PTCL comprises a biologically diverse group of aggressive, rare blood cancers that have a worse prognosis than most other types of lymphoma, including B-cell lymphoma. According to current CHMP guidelines, a final opinion on the re-examination could be issued by the EMA within four to five months.
“We believe FOLOTYN has the potential to offer an important new treatment option for patients with relapsed or refractory peripheral T-cell lymphoma, an indication for which there are currently no EMA-approved therapies and no accepted standard of care,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. “We look forward to working closely with our partner Mundipharma and the CHMP during the re-examination process.”
Pralatrexate has orphan medicinal product designation in Europe for the treatment of PTCL (nodal, other extranodal, and leukaemic/disseminated). In the E.U., orphan medicinal product designation is conferred upon investigational products for diseases that affect fewer than five in 10,000 patients. Products with orphan designation that are the first to be approved for a specific indication, and continue to meet the requirements for orphan designation, receive up to ten years of market exclusivity in the E.U.
FOLOTYN, a folate analogue metabolic inhibitor, was discovered by Sloan-Kettering Institute for Cancer Research, SRI International and Southern Research Institute and developed by Allos Therapeutics. 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.