Regulatory approval
Published by the Health Service Executive.
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).
Citation
Inotuzumab Ozogamicin Monotherapy, 2021, version number 2, NCCP National SACT Regimen, NCCP, viewed 03/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/537-inotuzumab-ozogamicin-monotherapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | CD22 + | Acute Lymphoid Leukemia | Inotuzumab ozogamicin | |
| Sensitivity (+) | BCR::ABL1, CD22 + | Acute Lymphoid Leukemia | Inotuzumab ozogamicin |