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 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 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 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
  4. The patient has been previously treated with intensive combination chemotherapy as initial treatment with or without subsequent salvage chemotherapy or blinatumomab
  5. The patient is an adult* *note there is a separate Blueteq form to be used for inotuzumab ozogamicin in this indication in children
  6. 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
  7. The patient has an ECOG performance status of 0 - 2
  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. No planned treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).* *Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process
  11. Inotuzumab ozogamicin will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 18 December 2018

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CDF Managed Access: NA

NICE Technology Appraisal: TA541 (19 September 2018)

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