Shots:

• 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