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Otsuka and Astex Report EMA's Acceptance of MAA for Fixed-Dose Combination of Decitabine and Cedazuridine to Treat Acute Myeloid Leukemia

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Otsuka and Astex Report EMA's Acceptance of MAA for Fixed-Dose Combination of Decitabine and Cedazuridine to Treat Acute Myeloid Leukemia

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  • The EMA has accepted the MAA for the oral fixed-dose combination of decitabine & cedazuridine (ASTX727) to treat adults with AML who are ineligible for intensive CT
  • The MAA was based on the P-III (ASCERTAIN) trial to evaluate PK of exposure equivalence of decitabine and cedazuridine vs IV decitabine which showed that the study met its 1EPs i.e., decitabine + cedazuridine showed exposure equivalence to a standard 5-day regimen of IV decitabine using a two-cycle cross-over study design. The safety results were generally consistent with those anticipated for IV decitabine
  • If decitabine and cedazuridine was approved, it will be the first oral hypomethylating agent licensed in the EEA for AML

Ref: Businesswire | Image: Astex

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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