Regulatory approval

Published by the Health Service Executive. Approved

Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult 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).

This is written in the approval document.

Reimbursement

ODMS

Citation

Inotuzumab Ozogamicin Monotherapy, 2021, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6981/537_v2_Inotuzumab.pdf

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
HSE (1) CD22 + Acute Lymphoid Leukemia Inotuzumab ozogamicin
HSE (1) CD22 +, not BCR::ABL1 Acute Lymphoid Leukemia Inotuzumab ozogamicin