April 16, 2009
FDA accepts NDA for Onrigin, a treatment for acute myeloid leukemiaVion Pharmaceuticals announced that the FDA has accepted for review its New Drug Application (NDA) for Onrigin (laromustine) injection, a remission induction treatment for acute myeloid leukemia (AML). The NDA is based on the results of an international multi-center Phase 2 trial of 85 patients ≥60 years of age with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase 2 trial in elderly AML. Eighty-six percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.
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