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).
Lineage
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| CD22-positive2 | ||||
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 | |
3 approvals for ALL need no biomarker and apply whatever the result. All approvals for ALL
See also
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.