Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved inotuzumab ozogamicin for reimbursement as a monotherapy treatment option for the treatment of adult patients with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia (ALL). The indication further states that 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 as:

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).

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

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2019-05-01	Health Service Executive	Indication approved for reimbursement.