Allos Therapeutics Starts Cancer Drug Trial

Successful data will support an expanded indication for Folotyn in the US in this patient population and to convert the current accelerated approval for relapsed and refractory PTCL to a full approval.

Biopharmaceutical company Allos Therapeutics has launched a Phase 3 clinical trial (PDX-017) evaluating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).

Folotyn, a folate analogue metabolic inhibitor, is approved in the US for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The randomised, open-label, multicentre, international PDX-017 study will enroll 549 patients to evaluate the safety and efficacy of Folotyn versus observation in patients with previously undiagnosed PTCL who have achieved an objective response following initial treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen. Th