# Inotuzumab ozogamicin

Inotuzumab ozogamicin (Besponsa, Pfizer Europe MA EEIG) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: CD22 (2).

## Approved indications

### Acute lymphoblastic leukaemia

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

## Products

### Besponsa

- Company: Pfizer Europe MA EEIG
- Target: CD22-directed antibody-drug conjugate
- Class: CD22 (clusters of differentiation 22) inhibitors
- ATC: L01FB01
- EU approval: 28 Jun 2017
- Label revised: 18 May 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/besponsa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/besponsa

Mechanism (SmPC section 5.1): Binds CD22-expressing tumour cells and internalises to intracellularly release calicheamicin, which induces double-stranded DNA breaks and apoptotic cell death.

## 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/drugs/inotuzumab-ozogamicin