Allos Therapeutics, Inc announced today that it has submitted a New Drug Application (NDA) to the FDA for the use of pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The company has requested that the FDA grant this application priority review, which would result in an accelerated process and a decision within six months. The filing includes the final results from the PROPEL trial released in early February in which patients receiving pralatrexate showed a 27% response rate. According to Allos CEO Paul Berns, “We plan to work closely with the FDA to facilitate the completion of their review as expeditiously as possible. There are currently no agents approved by the FDA for the treatment of patients with PTCL, which demonstrates the clear, high-unmet need for new therapies to treat patients with this devastating disease.”
Allos completed the PROPEL trial under the FDA’s Special Protocol Assistance program after receiving orphan drug designation. The company, which also received orphan drug designation in Europe for PTCL, did not state when it plans to file for approval in Europe. Allos, based in Westminster, Colorado, is developing pralatrexate, a targeted antifolate designed to accumulate preferentially in cancer cells, for use in other cancers including other lymphoma subtypes, bladder cancer, and non small cell lung cancer.
