Allos Therapeutics (Allos) has entered into a collaborative agreement with Idis, to manage the named patient program for Folotyn (pralatrexate injection) outside of the US. The FDA has granted accelerated approval for Folotyn for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Reportedly, the clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos retains exclusive worldwide rights to develop and commercialise Folotyn in all indications.
The company said that Folotyn has been available to patients in the US since October 2009, and is expected to be available under the named patient program outside the US in the beginning of January 2010.
The company also added that a named patient program is a mechanism through which physicians can legally and ethically prescribe investigational or approved drugs for patients prior to their commercial launch. Under the terms of the agreement, Idis will be the exclusive supplier of Folotyn to health care providers outside of the US on a named patient basis.
Paul Berns, president and CEO at Allos, sad: “We are pleased to partner with Idis, to provide access to Folotyn for patients with relapsed or refractory peripheral T-cell lymphoma outside the US. Importantly, this program will allow a greater number of patients with relapsed or refractory PTCL to potentially benefit from the use of Folotyn.”