Inotuzumab ozogamicin
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Acute lymphoblastic leukaemia2 | |||
CD22-positive | Monotherapy | 2L | 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 | 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 |
Full text of section 4.1 (therapeutic indications)
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). 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.
Label history
14 changes to the Besponsa label since 2018, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes