Shots:

• The approval is based on P-III ADMIRAL study assessing Xospata (120mg) vs salvage CT in 371 patients in a ratio (2:1) with r/r AML and FLT3 mutation in bone marrow or in whole blood
• The P-III ADMIRAL study results demonstrated longer OS (9.3 vs 5.6mos.)- rate of survival @1yr. (37% vs 17%)
• Xospata is the first and only targeted treatment approved by Health Canada for r/r AML with FLT3 mutation and has received approval in the US and Japan in 2018 and in EU in 2019

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Ref: Newswire Canda | Image: Astellas