The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Xospata (gilteritinib) should be granted a licence in the European Union (EU) for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
Gilteritinib inhibits FLT3 receptor signalling and proliferation and subsequently induces apoptosis in leukaemic cells expressing FLT3 internal tandem duplication (ITD). It will be available as 40 mg film-coated tablets.
Xospata was reviewed under the EMA’s accelerated assessment programme as the drug has already been shown to improve overall survival compared to salvage chemotherapy in this patient group.
The most common side effects are increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood alkaline phosphatase, diarrhoea, fatigue, nausea, constipation, cough, peripheral oedema, dyspnoea, dizziness, hypotension, pain in the extremities, asthenia, arthralgia and myalgia.
The CHMP decision will now be forwarded to the European Commission (EC) for a final decision. Detailed recommendations for the use of the product will be described in the summary of product characteristics, which will be published in all official EU languages after marketing authorisation has been granted by the EC.