Published

May 11, 2025

Inotuzumab ozogamicin [INO1]

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

  1. An application is being made by and the first cycle of systemic anti-cancer therapy with inotuzumab ozogamicin for each part of the treatment pathway will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The prescribing clinician is fully aware of the risk factors for inotuzumab ozogamicin inducing hepatotoxicity including veno-occlusive liver disease/sinusoidal obstruction syndrome and that this risk rises as the number of cycles administered increases.
  3. The patient has relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Please tick the appropriate box as to which type of ALL the patient has:
  • Philadelphia chromosome negative ALL
  • Philadelphia chromosome positive ALL in which case treatment with at least one TKI must have also failed
  1. The patient has been previously treated with intensive combination chemotherapy as initial treatment with or without subsequent salvage chemotherapy or blinatumomab.
  2. The patient is an adult. Note: there is a separate Blueteq form to be used for inotuzumab ozogamicin in this indication in children.
  3. Inotuzumab ozogamicin will only be requested by and administered in either bone marrow transplant centres or in major haematological centres that regularly treat patients with relapsed/refractory ALL and who have regular ALL multi-disciplinary team meetings and close links with bone marrow transplant centres.
  4. The patient has an ECOG performance status of 0 or 1 or 2.
  5. Inotuzumab is being used to treat relapsed or refractory ALL in one of the following settings: as a bridge to SCT or as a bridge to CAR T therapy or as treatment in a setting in which SCT and CAR T therapy are both inappropriate. Please mark the appropriate box which describes the setting in which inotuzumab is being used:
  • as a bridge to SCT or
  • as a bridge to CAR T therapy or
  • as treatment in a setting in which both SCT and CAR T therapy are inappropriate
  1. Confirm below whether this use of inotuzumab is the first ever use of the drug in this patient or is as re-treatment in a different place in the treatment pathway to the one previously used and in which case the patient must have responded to the prior inotuzumab. Please mark the appropriate box which indicates whether this is the first ever use of inotuzumab in this patient or is as re-treatment:
  • first ever use of inotuzumab in this patient or
  • is as re-treatment with inotuzumab in a different place in the treatment pathway and the patient responded to the prior inotuzumab
  1. The following treatment duration policies 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 or CAR T therapy, a lifetime maximum of 6 cycles of inotuzumab treatment may be administered. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment.
  • for patients having re-treatment with inotuzumab, there is a lifetime maximum of 6 cycles of inotuzumab.
  • for patients having re-treatment with inotuzumab which is being used as a bridge to SCT, it is recommended that no more than 3 cycles of inotuzumab are used across the entire pre-SCT pathway.
  1. Inotuzumab ozogamicin will be used as monotherapy.
  2. When a treatment break of more than 6 weeks beyond the expected 3- or 4-weekly cycle length is needed within each part of the treatment pathway as set out in criterion 8 above, the prescribing clinician will complete a treatment break approval form.
  3. Inotuzumab ozogamicin will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 18 December 2018

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 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.