Allos receives FDA fast track for lymphoma drug

Peripheral T-cell lymphomas, or PTCLs, are an uncommon group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin’s lymphoma, or about 6,700 patients annually. There are currently no pharmaceutical agents approved for use in the treatment of relapsed or refractory PTCL.

The fast track program is designed to facilitate the development and expedite the review of new drugs that demonstrate the potential to address unmet medical needs. A new drug application for a fast track product ordinarily qualifies for priority review, thereby further accelerating the FDA review process.

PDX is currently the subject of a pivotal phase II study that will seek to enroll 100 patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. The primary endpoint of the study is objective response rate.