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Active substances for the treatment of:

Myeloid leukaemia

Obejmuje przewlekłą białaczkę szpikową i ostrą białaczkę szpikową

Name of active substance (medicine) The European Society for Medical Oncology (ESMO). Published scientific research demonstrates that the observance of such scientific community guidelines has a positive impact on patient survival rates. Is it included in
the European standard  of treatment (according to ESMO)?
Access status (National Health Fund reimbursement) Additional information
Dasatinib The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Dasatinib is indicated for the treatment of adult patients with: - newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. - chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate. - Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib is indicated for the treatment of paediatric patients with: - newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. EPAR/SmPC Drug programme
Nilotinib The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Nilotinib is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. EPAR/SmPC Drug programme
Ponatinib The drug in this indication is not refunded No reimbursement Ponatinib is indicated in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. EPAR/SmPC
Bosutinib The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Bosutinib is indicated for the treatment of adult patients with: - newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML). - CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options. EPAR/SmPC Drug programme
Histamine dihydrochloride  The drug in this indication is not refunded No reimbursement Histamine dihydrochloride maintenance therapy is indicated for adult patients with acute myeloid leukaemia (AML) in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of histamine dihydrochloride has not been fully demonstrated in patients older than age 60. EPAR/SmPC
Azacitidine The drug in this indication is reimbursed for a narrower group of patients than is apparent from the ESMO guidelines Reimbursement with restrictions Azacitidine is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: • acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, • AML with >30% marrow blasts according to the WHO classification. EPAR/SmPC Drug programme
Decitabine The drug in this indication is not refunded No reimbursement Decitabine is indicated for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy. EPAR/SmPC
Midostaurin The drug in this indication is not refunded No reimbursement Midostaurin is indicated: - in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive. EPAR/SmPC
Gemtuzumab ozogamicin The drug in this indication is not refunded No reimbursement Gemtuzumab ozogamicin is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL). EPAR/SmPC
Daunorubicin / cytarabine The drug in this indication is not refunded No reimbursement Daunorubicin / cytarabine is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). EPAR/SmPC