The European Medicines Agency has issued a positive opinion for the personalised therapy Xospata (gilteritinib) to treat acute myeloid leukaemia (AML) following approvals for the same drug in both the US and Japan. The developer is Tokyo-based Astellas Pharma Inc.
Xospata is being recommended as a monotherapy for the treatment of adult patients with relapsed or refractory AML with a FLT3 gene mutation. The positive opinion will need to be adopted by the European Commission before Xospata can be marketed.