Allos’ T-Cell Lymphoma Drug on Fast Track

U.S. firm Allos Therapeutics said Wednesday it has received fast-track review status for its T-cell lymphoma drug, PDX.

The Food and Drug Administration grants such status to drugs that treat serious diseases for which there is an unmet medical need.

The designation means Allos’ new drug application will likely be reviewed within six months and also allows the company to use safety and efficacy data collected from an earlier point in the clinical trials to help speed the treatment’s development.

We are extremely pleased that the FDA has recognized the urgent and unmet medical need for effective new therapies for the treatment of patients with T-cell lymphoma, said Paul Berns, president and chief executive officer. Fast track designation represents a significant regulatory milestone in the development of PDX, and further validates the potential of PDX in this patient population.

The company said it is currently testing PDX in an international phase 2 study, which will enroll as many as 100 patients with relapsed or refractory PTCL whose condition has progressed following at least one prior treatment. Allos said it expects to complete enrollment at 35 sites in the United States, Europe and Canada by the third quarter of 2008.