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EMA Recommends Granting a Marketing Authorisation for Gilteritinib

It is indicated for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation
20 Sep 2019
Targeted Therapy;  Cytotoxic Therapy
Haematological Malignancies

On 19 September 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product gilteritinib (Xospata), intended for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. Xospata was reviewed under EMA’s accelerated assessment programme, reserved for medicines of major public health interest.

The applicant for this medicinal product is Astellas Pharma Europe B.V.

Xospata will be available as 40-mg film-coated tablets. The active substance of Xospata is gilteritinib, a protein kinase inhibitor (ATC code: L01XE54) which inhibits FLT3 receptor signalling and proliferation in cells and subsequently induces apoptosis in leukaemic cells expressing FLT3 ITD.

The benefit with Xospata is its ability to improve overall survival compared to salvage chemotherapy.

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 full indication is: Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation.

It is proposed that Xospata be prescribed by physicians experienced in the use of anti-cancer therapies.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained. AML is a rare type of malignancy. It affects approximately 1 in 10,000 people in the European Union.

Last update: 20 Sep 2019

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