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Astellas Reports XOSPATA, Azacitidine Combination Did Not Meet Endpoint americanpharmaceuticalreview
December 23, 2020
Astellas Pharma announced that a Phase 3 trial of XOSPATA® (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction ...
NICE publishes guidance on Astellas' Xospata pharmatimes
August 18, 2020
The National Institute for Health and Care Excellence has now published final guidance backing NHS use of Astellas' Xospata as monotherapy for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML).
NICE backing for Astella's Xospata pharmatimes
July 20, 2020
NICE has recommended use of Astellas' Xospata (gilteritinib) for adults with relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML).
EMA CHMP recommends seven medicines for approval europeanpharmaceuticalreview
September 25, 2019
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
Astellas Launches XOSPATA for Relapsed/Refractory AML with a FLT3 Mutation americanpharmaceuticalreview
December 12, 2018
Astellas Pharma announced that XOSPATA (gilteritinib) is now available for prescription in the United States for the treatment of adult patients who have relapsed .....
Astellas scores first US blood cancer approval with Xospata pharmaphorum
December 03, 2018
The FDA has approved Astellas’ Xospata for certain patients with acute myeloid leukaemia – the company’s first drug approved in blood cancer.
Astellas' Xospata becomes US-approved drug for FLT3-mutated acute myeloid leukaemia pharmafile
November 30, 2018
Astellas has revealed that Xospata (gilteritinib) has been awarded FDA approval as a treatment for relapsed or refractory acute myeloid leukaemia (AML) with an FLT3 mutation – a first for the US regulator in this indication.
FDA Approves Xospata drugs
November 29, 2018
FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation.