First Approval Globally For Gilteritinib, In Japan For AML
First nod globally for Astellas's FLT3 inhibitor set to further increase competition in AML space, but commercial opportunity in launch market Japan looks set to be limited.
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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.
Oncology again dominated new drug approvals in Japan last fiscal year, when expedited and special review pathways also played a major role in ensuring early access to new therapies.
This year's ASH meeting reflected a peak of development success, with many new approvals and many more in the pipeline.