Dasatinib [DAS4]

Dasatinib for treating imatinib-resistant imatinib-intolerant Philadelphia chromosome positive chronic phase chronic myeloid leukaemia in children where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with dasatinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has Philadelphia chromosome positive CML in chronic phase.
  3. The patient has been previously treated with imatinib which had to be discontinued due to resistance or intolerance. Please mark below whether the patient was resistant to or intolerant of imatinib:
  • resistant to imatinib or
  • intolerant of imatinib or
  1. The use of dasatinib has been discussed by the relevant multi-disciplinary team (MDT) involved in chronic myeloid leukaemia (CML) decision making, 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.
  2. The patient is a child and I understand the Summary of Product Characteristics (SPC) states that ‘there is no experience with treatment of paediatric patients below 2 years of age’ and ‘there is limited data in imatinib-resistant or intolerant paediatric patients below 6 years of age’.
  3. Treatment with dasatinib will be as monotherapy and with dosing appropriate to the tablet formulation or the oral suspension as described in the separate tablet and oral suspension Summaries of Product Characteristics (SPCs).
  4. The prescribing clinician understands the SPC cautions that in paediatric patients after at least 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported and close monitoring of growth in paediatric patients under dasatinib treatment is therefore recommended.
  5. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID19.
  6. Dasatinib will otherwise be used as outlined in the Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 21 March 2017

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CDF Managed Access: NA

NICE Technology Appraisal: referenced TA425 (21 December 2016)

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