# Acalabrutinib

Acalabrutinib (Calquence, AstraZeneca AB) has 6 EU-approved indications in 2 tumour types.

## Approved indications

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + obinutuzumab | 1st line | - |
| None | + venetoclax with or without obinutuzumab | 1st line | - |
| None | Monotherapy | 1st line | - |
| None | Monotherapy | 2nd line | After at least one prior therapy |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + bendamustine and rituximab | 1st line | Not eligible for autologous stem cell transplant (ASCT) |
| None | Monotherapy | 2nd line | No prior BTK inhibitor |

## Products

### Calquence

- Company: AstraZeneca AB
- Target: Selective BTK inhibitor
- Class: Bruton's tyrosine kinase (BTK) inhibitors
- ATC: L01EL02
- EU approval: 5 Nov 2020
- Label revised: 7 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/calquence-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/calquence

Mechanism (SmPC section 5.1): Acalabrutinib covalently binds to the active site of Bruton tyrosine kinase (BTK), irreversibly inactivating it to block B-cell survival, proliferation, and trafficking.

## Label wording

- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 1st line: “Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 1st line: “Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 1st line: “Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 2nd line: “Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Mantle cell lymphoma, 1st line: “Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Mantle cell lymphoma, 2nd line: “Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-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/acalabrutinib