FDA fast tracks Rx for hard-to-treat peripheral T-cell lymphoma

Allos Therapeutics has received accelerated FDA approval for Folotyn (pralatrexate) as a single-agent treatment in patients with relapsed or refractory peripheral T-cell lymphoma.

The company's new drug application was based on data from the PROPEL trial, which showed positive results for overall response. Improvement in progression-free survival or overall survival has not been demonstrated, according to Allos. The company will perform more studies to verify the clinical benefit of pralatrexate in T-cell lymphoma.