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news.Vion Pharmaceuticals (Vion) had received a response from the FDA on a special protocol assessment (SPA) for its oncology therapeutic Onrigin (laromustine) injection.
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Earlier, in January 2010, Vion has filed a SPA with the FDA related to a randomised Phase II/III trial of Onrigin in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). In its response, the FDA requested that the company conduct a separate Phase II trial of Onrigin and review the results of this trial with the FDA prior to conducting a Phase III trial.
Vion said that the SPA process is intended to evaluate a Phase III protocol whose data is expected to form the primary basis for an efficacy claim.
Vion said that the Phase II/III randomised trial for which the company filed has the SPA had been designed in response to the FDA’s complete response letter to the company’s New Drug Application for Onrigin that required a randomised trial be conducted to support the approval of Onrigin for the treatment of AML.