Asciminib
Asciminib (Scemblix, Novartis Europharm Limited) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: BCR::ABL1 (2).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Chronic myeloid leukaemia2 | |||
Philadelphia chromosome or BCR-ABL1 fusion | Monotherapy | Any line | Chronic phase only |
T315I, Philadelphia chromosome-positive | Monotherapy | Any line | Chronic phase only; Resistant to, intolerant to or ineligible for ponatinib |
Full text of section 4.1 (therapeutic indications)
Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) (see section 5.1). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).
Label history
14 changes to the Scemblix label since 2023, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes