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Astex Eyes First Filing For Oral Decitabine On Positive Combo Results

 
• By Ian Haydock

Otsuka subsidiary Astex plans filing in MDS by year-end for first oral decitabine product on the back of positive Phase III comparative results.

Destruction of leukaemia cell, conceptual image. 3D illustration which can be used to illustrate blood cancer treatment
Oral Decitabine Brings Dosing Convenience • Source: Shutterstock

Otsuka Pharmaceutical Co. Ltd. subsidiary Astex Pharmaceuticals Inc. plans to file for the US approval of ASTX727, an oral fixed-dose combination of decitabine and cedazuridine, by the end of this year, after the product met its primary endpoint in a Phase III trial.

The positive top-line results came from the 138-patient, open-label ASCERTAIN study in North America with the combo versus intravenous decitabine, in adults with intermediate or high risk, treated or untreated

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