Inotuzumab ozogamicin [INO2]

The treatment of relapsed/refractory Philadelphia positive and negative B cell precursor acute lymphoblastic leukaemia in CHILD patients where all the following criteria are met:

1. An application has been made by and the first cycle of systemic anti-cancer therapy with inotuzumab ozogamicin will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
2. The patient has relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Please tick appropriate box as to which type of ALL the patient has: * Philadelphia chromosome negative ALL or * Philadelphia chromosome positive ALL in which case treatment with at least one second or third generation TKI must have also failed
3. The patient has been previously treated with intensive combination chemotherapy as initial treatment with or without subsequent salvage chemotherapy or blinatumomab
4. The patient is a child* and meets one of the following criteria (select the appropriate option)

• is post-pubescent, and the dose given will be as per the Summary of Product Characteristics
• is pre-pubescent and will receive inotuzumab ozogamicin at the dosage described in the results of the inotuzumab ozogamicin trial in children and reported in Pediatric Blood Cancer 2014; 61: 369-372 doi: 10.1002/pbc.24721
• is a patient aged <18, treated on the UKALL 2025 (CCLG) blinatumomab guidelines who also meets the definition of blinatumomab failure and is proposed to receive inotuzumab prior to ongoing intensive chemotherapy. This treatment/dosing strategy must be recommended by the national leukaemia MDT, and patients may then receive inotuzumab at the dosage described in Journal of Clinical Oncology, J Clin Oncol 41, 10016(2023) ‘A phase 3 trial of inotuzumab ozogamicin for high- risk B-ALL: Second safety phase results from Children’s Oncology Group AALL1732’ *Note there is a separate Blueteq form to be used for inotuzumab ozogamicin in this indication in adults.

5. Inotuzumab ozogamicin will only be requested by and administered in principal treatment centres
6. The use of inotuzumab has been discussed by the relevant multi-disciplinary team (MDT), which must include at least two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician or a consultant with a Certificate of Completion of Training (CCT) which includes training in caring for children. The MDT should include a paediatric pharmacist, and other professional groups appropriate to the disease area.
7. The patient has a Karnofsky/Lansky performance score of >50
8. The following treatment duration policy will apply to the use of inotuzumab ozogamicin: for those patients proceeding to a stem cell transplant (SCT), the recommended duration of treatment is 2 cycles. A 3rd cycle may be considered for those patients who do not achieve a complete remission (CR) or a CR with incomplete haematological recovery (CRi) and minimal residual disease negativity after 2 cycles. For patients not proceeding to a SCT, a maximum of 6 cycles of treatment may be administered. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment
9. Inotuzumab ozogamicin will be used as monotherapy
10. When a treatment break of more than 6 weeks beyond the expected 3- or 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is recommenced.
11. Trust policy regarding unlicensed treatments has been followed as inotuzumab ozogamicin is not licensed in this indication in children
12. Inotuzumab ozogamicin will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 18 December 2018

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA541 (19 September 2018)

Current Form Version

Note

The data on this page was produced using version 1.406 of the CDF list, downloaded from NHS England’s website on 09 September 2026 at 21:36.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• INO2_prior_to_cdf_1.361
• INO2_prior_to_cdf_1.406