dm+d

37898211000001109

New Medicines

XospataAcute myeloid leukaemia (AML) in patients with FLT3 mutation - maintenance therapy following hematopoietic stem cell transplant

Information

Xospata
Licence extension / variation
Astellas
Astellas

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

FMS-like tyrosine kinase 3 (FLT-3) inhibitor
The incidence of the AML in European adults is 5-8 cases per 100,000 [3]. Incidence of FLT-3 mutation in AML is 20-30%, and is associated with poorer prognosis [4,5].
Acute myeloid leukaemia (AML) in patients with FLT3 mutation - maintenance therapy following hematopoietic stem cell transplant
Oral

XospataNewly diagnosed acute myeloid leukaemia (AML) - first-line with high intensity induction chemotherapy in patients with FLT3 mutation

Information

Xospata
Licence extension / variation
Astellas
Astellas

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

FMS-like tyrosine kinase 3 (FLT-3) inhibitor
The incidence of the AML in European adults is 5-8 cases per 100,000 [2]. Incidence of FLT-3 mutation in AML is 20-30%, and is associated with poorer prognosis [1,2].
Newly diagnosed acute myeloid leukaemia (AML) - first-line with high intensity induction chemotherapy in patients with FLT3 mutation
Oral

XospataAcute myeloid leukaemia (AML) - maintenance therapy for patients with FLT3 mutation in first complete remission following induction/consolidation chemotherapy

Information

Xospata
Licence extension / variation
Astellas
Astellas

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

FMS-like tyrosine kinase 3 (FLT-3) inhibitor
The incidence of the AML in European adults is 5-8 cases per 100,000 [2]. Incidence of FLT-3 mutation in AML is 20-30%, and is associated with poorer prognosis [3,4].
Acute myeloid leukaemia (AML) - maintenance therapy for patients with FLT3 mutation in first complete remission following induction/consolidation chemotherapy
Oral