CD22
2 EU-approved indications of 1 drug need a CD22 result, in 1 tumour type, most of them in acute lymphoblastic leukaemia.
Approved indications2
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Acute lymphoblastic leukaemia2 | ||||
Besponsa | Monotherapy | 2L | B-cell precursor ALL only; Relapsed or refractory disease; patients with Ph+ disease should have failed treatment with at least 1 TKI | |
Besponsa | Monotherapy | 2L | 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 | |
CD22 by tumour
Label wording2
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Inotuzumab ozogamicin (Besponsa)
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).
- Inotuzumab ozogamicin (Besponsa)
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.