Sorafenib [SOR6]

Sorafenib maintenance for the treatment of FLT3-Internal Tandem Duplication (FLT3- ITD) acute myeloid leukaemia (AML) post allogeneic haematopoietic stem cell transplantation (allo-HSCT) IN POST- PUBESCENT CHILDREN where the following criteria are met:

  1. An application has being made by and the first cycle of systemic anti-cancer therapy with sorafenib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a diagnosis of FLT3-Internal Tandem Duplication (FLT3-ITD) mutation acute myeloid leukaemia (AML).
  3. The patient is a post-pubescent child receiving access under the Medicines for Children policy.
  4. Sorafenib is not licensed for FLT3-ITD mutation AML maintenance therapy post allogeneic haematopoietic stem cell transplantation (allo-HSCT) and therefore Trust policy regarding unlicensed medicines has been followed.
  5. The patient has been discussed by a relevant specialist MDT and it has been agreed that sorafenib is the most appropriate therapy. This MDT must include at least two consultants with experience in the treatment of FLT3-ITD AML of whom at least one must be a consultant paediatrician. The MDT should also include a paediatric pharmacist and other professional groups appropriate to the disease area.
  6. I confirm that sorafenib in this indication is to be used as monotherapy and not combined with any other maintenance therapy and that the patient will receive the recommended dosing of sorafenib as outlined in the NHS England Clinical Commissioning Policy and the product’s Summary of Product Characteristics.
  7. The patient meets all of the following eligibility criteria: o has undergone allogeneic haematopoietic stem cell transplantation AND o Exhibits adequate engraftment (absolute neutrophil count of at least 1.0 x 10⁹/L and a non-transfused platelet count of at least 30 x 10⁹/L) at the time of sorafenib initiation.
  8. The patient does not meet any one of the following exclusion criteria: o Individuals with contraindications to sorafenib, as outlined in the summary of product characteristics (SPC) OR o Uncontrolled graft versus host disease (GvHD) OR o Persistent liver dysfunction (total bilirubin twice or more the upper limit of normal [ULN] or alanine aminotransferase or aspartate aminotransferase twice or more the ULN) OR o Persistent renal dysfunction (creatinine twice or more the ULN or creatinine clearance <30mL/min) OR o Individuals with severe concomitant conditions for whom the MDT determines that sorafenib maintenance cannot be delivered safely.
  9. The patient has not been previously treated with sorafenib unless the patient received sorafenib via the Bayer compassionate access scheme in which case all other treatment criteria on this form must be fulfilled.
  10. Treatment with sorafenib maintenance therapy will commence no later than 4 months after the date of allo-HSCT and continue for up to a maximum of 24-months post allo-HSCT. Note: the 24 months duration is fixed and starts from the date of the allo-HSCT regardless of the actual start date of sorafenib or the need for any treatment breaks. Ticking this criterion is also confirming that the patient and/or carer have been informed and consented (as appropriate) to future discontinuation of sorafenib no later than 24 months after the date of allo-HSCT.
  11. Treatment with sorafenib maintenance therapy will be stopped at whichever of the following events occurs first; completion of 24-month duration after the date of allo-HSCT, grade 3 or grade 4 GvHD, disease progression or withdrawal of patient consent, whichever is the sooner.
  12. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
  13. Sorafenib will otherwise be used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 06 December 2023

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CDF Managed Access: NA

NICE Technology Appraisal: NHSE Policy: URN2262 (NA)

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