# CD22 in acute lymphoblastic leukaemia

2 EU-approved indications in acute lymphoblastic leukaemia need a CD22 result: inotuzumab ozogamicin (2nd line) and inotuzumab ozogamicin (2nd line).

## Approved indications

### CD22-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Inotuzumab ozogamicin](https://oncolabels.com/drugs/inotuzumab-ozogamicin) (Besponsa) | CD22-positive | Monotherapy | 2nd line | B-cell precursor ALL only; Relapsed or refractory disease; patients with Ph+ disease should have failed treatment with at least 1 TKI |
| [Inotuzumab ozogamicin](https://oncolabels.com/drugs/inotuzumab-ozogamicin) (Besponsa) | CD22-positive | Monotherapy | 2nd line | B-cell precursor ALL only; Children and adolescents only; In first relapse after allo-HSCT, or after any first relapse in VHR disease, or after a second or greater relapse, or refractory disease; patients with Ph+ disease should have exhausted relevant BCR-ABL targeting treatment options; Aged 1 year and older |

## Label wording

- **Inotuzumab ozogamicin** (Besponsa), Acute lymphoblastic leukaemia, 2nd line: “BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B-cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf)
- **Inotuzumab ozogamicin** (Besponsa), Acute lymphoblastic leukaemia, 2nd line: “BESPONSA is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B-cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/besponsa-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/tumours/acute-lymphoblastic-leukaemia/cd22