Vion files new drug application for leukemia drug

Vion Pharmaceuticals, a developer of therapeutics for the treatment of cancer, has filed a new drug application with the FDA for its lead oncology therapeutic Onrigin injection as a single agent for remission induction treatment for patients 60 years of age or older with de novo poor-risk acute myeloid leukemia.

The Onrigin new drug application (NDA) submission is based on the results of an international multi-center pivotal Phase II trial of 85 patients 60 years of age or older with de novo poor-risk acute myeloid leukemia (AML), supplemented by data from 55 patients in a previous Phase II trial in elderly AML.

The company has also requested a priority review for the application and, if granted, Onrigin could receive approval for this indication in the second half of 2009.

Alan Kessman, CEO of Vion, said: This NDA filing is a significant milestone for Vion and for the Onrigin clinical development program. Acute myeloid leukemia is a devastating disease, and patients and their physicians are seeking new treatment options that can provide the opportunity for achieving a complete response. We are excited to be taking this major step towards achieving the FDA approval for Onrigin.