Primo-indication
Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
Intervention Type
Pharmaceutical
Solid/Hematological
Hematological
Cancer Type
Leukemia
Therapy Types
Chemotherapy
Regulatory
FDA
N/A
Regulatory Pathway: n/a
EMA
17.06.2021
Regulatory Pathway: standard approval
Availability in other countries
N/A
Focus Area
Cancer
ASMR
III
Medical Need
Unmet
SMR
IMPORTANT
Orphan Status
No