![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » ALLOS' PDX GETS FAST-TRACK DESIGNATION FOR LYMPHOMA
ALLOS' PDX GETS FAST-TRACK DESIGNATION FOR LYMPHOMA
October 3, 2006
Allos announced that the FDA has granted fast-track designation to the company's unique next-generation antifolate PDX (pralatrexate) for the treatment of patients with T-cell lymphoma.
The fast-track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation allows a company to submit portions of a new drug application (NDA) on a rolling basis, allowing the FDA to review sections of the NDA prior to receiving the complete application. In addition, an NDA for a fast track product ordinarily qualifies for priority review, further expediting the FDA review process.
PDX is currently the subject of a Phase II, international, multicenter, open-label, single-arm study that will seek to enroll 100 patients with relapsed or refractory peripheral T-cell lymphoma who have progressed after at least one prior treatment. The primary endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, progression-free survival and overall survival.
PDX is a small-molecule chemotherapeutic agent that inhibits dihdrofolate reductase (DHFR), a folic acid (folate) dependent enzyme involved in the building of DNA and other processes. PDX was rationally designed for improved transport into tumor cells via the reduced folate carrier (RFC-1) and greater intracellular drug retention. These biochemical features, together with preclinical data in a variety of tumors, suggest that PDX has an enhanced potency and improved toxicity profile relative to methotrexate and other related DHFR inhibitors.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct