# Asciminib

Asciminib (Scemblix, Novartis Europharm Limited) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: BCR::ABL1 (2).

## Approved indications

### Chronic myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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 |

## Products

### Scemblix

- Company: Novartis Europharm Limited
- Target: Allosteric BCR::ABL1 inhibitor (myristoyl pocket)
- Class: BCR-ABL tyrosine kinase inhibitors
- ATC: L01EA06
- EU approval: 25 Aug 2022
- Label revised: 7 Aug 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/scemblix-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/scemblix

Mechanism (SmPC section 5.1): Binds the ABL myristoyl pocket of the BCR::ABL1 fusion protein, inhibiting its ABL1 tyrosine kinase activity.

## Label wording

- **Asciminib** (Scemblix), Chronic myeloid leukaemia, any line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf)
- **Asciminib** (Scemblix), Chronic myeloid leukaemia, any line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/asciminib