Astellas' Phase III Front-Line AML Study Of Xospata Fails

Standard Of Care Has Shifted Since Trial's Initiation

 
• By Alaric DeArment
  
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One expert said the company should focus efforts on developing the drug for maintenance treatment of AML.

Acute myeloid leukemia a 3d-Render
Astellas said its Phase III study of Xospata in front-line AML did not show an overall survival benefit. • Source: Shutterstock

Development of Astellas Pharma, Inc.’s Xospata (gilteritinib) in acute myeloid leukemia (AML) may benefit from taking into account dramatic shifts since 2018 in the standard of care, following the failure of a Phase III clinical trial in newly diagnosed patients ineligible for intensive chemotherapy. The company had been hoping to expand Xospata into a new indication earlier in the treatment landscape.

However, the introduction of AbbVie Inc. and Roche Holding AG’s Venclexta (venetoclax), which is fully approved for a...

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