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Vion Pharmaceuticals Inc.

Division of Sumitomo Chemical Co./Sumitomo Dainippon Pharma Co. Ltd./Sunovion Pharmaceuticals Inc./Elevation Pharmaceuticals Inc.
www.vionpharm.com

Latest From Vion Pharmaceuticals Inc.

Dacogen Leukemia Indication Would Require New Clinical Trial, FDA Tells Eisai

The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia because the pivotal study failed to demonstrate a statistically significant survival benefit in the pre-specified primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.

BioPharmaceutical Advisory Committees

Dacogen Leukemia Indication Needs New Clinical Trial, FDA Tells Eisai

The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia, pointing to the failure of the pivotal trial to show a survival benefit on primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.

BioPharmaceutical Clinical Trials

Eisai Will Make “Totality Of The Evidence” Argument At FDA Panel Review Of Dacogen

Briefing documents for the Oncologic Drugs Advisory Committee’s Feb. 9 meeting suggest Eisai will argue that the totality of the data on decitabine’s efficacy and safety in elderly patients with acute myelogenous leukemia is sufficient to overcome the pivotal trial’s failure to show a statistically significant overall survival benefit in the primary analysis. In contrast, FDA’s review takes a laser-like focus on the failed primary endpoint.

BioPharmaceutical Advisory Committees

Chroma/CTI plan tosedostat PhIII to avoid AML trap that caught Vion, J&J and Genzyme

The mood of de-risking that prevails in the life sciences at the moment means that the transition of its lead compound tosedostat from Phase II studies to two Phase III registrational trials for acute myeloid leukaemia (AML) in 2012 is a crucial step for Chroma Therapeutics, the UK-based originator of the molecule and for Cell Therapeutics Inc., Chroma's US-based licensee for the Americas (North, South and Central).

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