The FDA has granted accelerated approval for Allos Therapeutics’ FOLOTYN(pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Reportedly, 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 US in October.
The company’s New Drug Application (NDA) for FOLOTYN was based on data from the PROPEL trial.
Paul Berns, president and chief executive officer at Allos Therapeutics, said: “We are enthusiastic about providing this new therapy to patients with relapsed or refractory PTCL. The approval of FOLOTYN is a transformative event for Allos representing our first US 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.”
Peter Saltonstall, president and chief executive officer of the National Organization for Rare Disorders (NORD), said: “The approval of FOLOTYN brings a new treatment option to patients afflicted with peripheral T-cell lymphoma. 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.