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

Published on 28/10/19 at 10:13am

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.

Additionally, 37% of Xospata patients survived for one year following diagnosis, compared to 17% with salvage chemotherapy.

The decision was reached under accelerated assessment, granted by the EMA earlier this year.

“AML is a rare cancer and patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy,” remarked Dr Giovanni Martinelli of the Institute of Hematology, S Orsola-Malpighi University Hospital in Italy, who served as a trial investigator. “Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”

Dr Andrew Krivoshik, Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas, added: “Today’s approval marks a significant advance for patients living with relapsed or refractory, FLT3 mutation-positive acute myeloid leukaemia. We look forward to working with health authorities across the EU to bring gilteritinib to patients who need it the most, as soon as possible.”

Matt Fellows

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