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European approval announced for Astellas' Xospata in FLT3+ treatment-resistant acute myeloid leukaemia

06:13 EDT 28 Oct 2019 | Pharmafile

Astellas has revealed that the European Commission has awarded marketing approval for Xospata (gilteritinib) as an oral, once-daily monotherapy for the treatment of relapsed or refractory (resistant to treatment) acute myeloid leukaemia (AML) in adult patients whose tumour exhibits a FLT3 mutation (FLT3mut+).

Strong Phase 3 data for the drug drove the decision, demonstrating that the use of Xospata “significantly” extended overall survival compared to salvage chemotherapy, while median rates recorded as 9.3 months versus 5.6 months respectively.

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Original Article: European approval announced for Astellas' Xospata in FLT3+ treatment-resistant acute myeloid leukaemia

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