Vion’s NDA for cancer drug accepted for review by FDA

Vion Pharmaceuticals has reported that the new drug application for its lead oncology therapeutic Onrigin injection has been accepted for review by the FDA.

The NDA presents data for Onrigin as a single agent for remission induction treatment for patients 60 years of age or older with de novo poor-risk acute myeloid leukemia (AML).

The NDA 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 AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML.

Alan Kessman, CEO of Vion, said: Acceptance of our NDA filing for review is important for Vion. We will continue to work closely with the FDA on the filing with the objective of achieving approval for Onrigin in its first indication in the US.

Vion Pharmaceuticals is engaged in improving the quality of life of cancer patients by developing and  commercializing innovative oncology therapeutics. It has two agents in clinical trials, Onrigin (laromustine) Injection and Triapine. The FDA is reviewing a New Drug Application for Onrigin for remission induction treatment for patients sixty years of age or older with de novo poor-risk AML. Triapine, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute.