Astellas Pharma announced that the European Commission (EC) has approved its XOSPATA (gilteritinib) as an oral once-daily therapy for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (FLT3mut+).

Astellas has developed gilteritinib under a research collaboration with Kotobuki Pharmaceutical and holds exclusive global rights to develop, manufacture, and commercialise the drug.

Astellas oncology development senior vice president and global therapeutic area head Andrew Krivoshik said: “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.”

EC approval of XOSPATA is based on Phase 3 ADMIRAL study results

Astellas has secured the US and Japan regulatory approvals in 2018 for gilteritinib for the treatment of patients with relapsed or refractory FLT3mut+ AML

In addition, the company is currently investigating gilteritinib in different FLT3 mutation-positive AML patient populations through several clinical trials.

Astellas said that gilteritinib is capable of improving treatment outcomes for AML patients with FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) mutations, and the treatment with gilteritinib has resulted in longer overall survival (OS) compared with that of salvage chemotherapy.

The EC approval of XOSPATA is based on results from the Phase 3 ADMIRAL clinical trial of gilteritinib compared with salvage chemotherapy, and the EC marketing authorization allows the commercialisation of the drug in the European Union (EU) member countries, and in Iceland, Norway and Liechtenstein.

Investigator in the ADMIRAL trial Giovanni Martinelli said: “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.

“Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”