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Astellas Misses Again On Xospata Label Expansion Effort

 
• By Joseph Haas

A Phase III disappointment in a maintenance therapy setting for FLT3-mutated acute myeloid leukemia is yet another failed attempt by Astellas to add to Xospata’s label since US FDA approval in 2018.

Astellas Northbrook, IL
Astellas still has other avenues to label expansion for Xospata • Source: Shutterstock

Astellas Pharma, Inc.’s hopes for adding to the US label for Xospata in a mutated form of acute myeloid leukemia fell by the wayside on 9 March as the company revealed that the Phase III MORPHO study, which could have moved the drug into an earlier line of therapy, failed to meet its primary endpoint. The Tokyo-based firm will continue reviewing the study’s full dataset but said the trial will be stopped as it did not show a benefit for relapse-free survival (RFS) in the primary analysis.

Xospata (gilteritinib) is a second-generation inhibitor of FMS-like tyrosine kinase 3 (FLT3), mutations of which are associated with poorer therapeutic...

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