Allos Therapeutics, Inc. has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for the use of pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The company has requested a priority review of the application. There are currently no agents approved by the FDA for the treatment of patients with PTCL.
Pralatrexate is a novel, targeted antifolate designed to accumulate preferentially in cancer cells. Acting on the folate pathway, pralatrexate interferes with DNA synthesis and triggers cell death.
The NDA for pralatrexate is based on results from the pivotal Phase II trial known as PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral T-cell Lymphoma). In this international, multicenter, open-label, single-arm trial, 27% of patients achieved a response to treatment; median duration of response was 9.4 months.