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Astex Reports Results of Decitabine and Cedazuridine (ASTX727 or DEC-C) in P-III (ASCERTAIN) Trial as Fixed-Dose Combination for Acute Myeloid Leukemia

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Astex Reports Results of Decitabine and Cedazuridine (ASTX727 or DEC-C) in P-III (ASCERTAIN) Trial as Fixed-Dose Combination for Acute Myeloid Leukemia

Shots:

  • The P-III (ASCERTAIN) study evaluates decitabine + cedazuridine (ASTX727 or DEC-C) as a fixed-dose combination vs IV decitabine in adults with AML
  • The study met its 1EPs i.e., the combination provides exposure equivalence to IV decitabine at 5-day dosing, and safety results were similar to IV decitabine. The results will be presented at EHA 2022 in Vienna, Austria
  • The company intends to submit an MAA to EMA & equivalent applications in other countries where IV decitabine is used to treat AML. The oral combination is being studied for hematological malignancies in combination with other agents & was approved as Inqovi in the US & Canada for intermediate and high-risk MDS including CMML

Ref: Businesswire | Image: Astex

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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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