Nilotinib
Nilotinib (Tasigna, Novartis Europharm Limited) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: BCR::ABL1 (3).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Chronic myeloid leukaemia3 | |||
Philadelphia chromosome positive | Monotherapy | 1L | Chronic phase |
Philadelphia chromosome positive | Monotherapy | 2L | Resistance or intolerance to prior therapy including imatinib; Chronic phase or accelerated phase |
Philadelphia chromosome positive | Monotherapy | 2L | Children and adolescents only; Resistance or intolerance to prior therapy including imatinib; Chronic phase |
Full text of section 4.1 (therapeutic indications)
Tasigna 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.
Label history
57 changes to the Tasigna label since 2008, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes