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Published

May 11, 2025

Brentuximab [BRE10 (formerly BRE1)]

The treatment of relapsed or refractory systemic anaplastic large cell lymphoma CHILD patients, where the following criteria have been met:

  1. An application has been made and the first cycle of systemic anti-cancer therapy is to 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 systemic anaplastic large cell lymphoma after front line chemotherapy Note: Brentuximab is not available for 1° cutaneous anaplastic large cell lymphoma unless it has transformed into systemic anaplastic large cell lymphoma
  3. Histologically confirmed CD30 positive disease
  4. The patient has never previously received brentuximab unless previously enrolled in the NCRI-adopted clinical trial called ECHELON-2
  5. Brentuximab is to be used as single-agent therapy
  6. The patient has an ECOG performance status of 0-1
  7. The patient is a child* and either post pubescent or is pre pubescent and will receive brentuximab vedotin dosage as described in phase 2 of the trial protocol C25002 http://www.clinicaltrials.gov/ct2/show/NCT01492088?term=C25002&rank=1 and reported on http://www.bloodjournal.org/content/122/21/4378 in Note: there is a separate Blueteq form to be used for brentuximab vedotin in this indication in adults
  8. The use of brentuximab in this setting and in this patient has been discussed at a multi-disciplinary team (MDT) meeting which must include at least 2 consultants in the subspecialty with active and credible expertise in the relevant field of whom one must be a consultant paediatrician. The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area
  9. Treatment with brentuximab to be discontinued after 4 cycles if CT or PET-CT scans to assess response demonstrate a response status of less than a partial or a complete response
  10. No 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)* *Note: Requests for continuation of treatment after unplanned treatment breaks over this duration should be made via the treatment break approval process
  11. Brentuximab vedotin will only be requested by and administered in principal treatment centres 12.Trust policy regarding unlicensed treatments has been followed as brentuximab vedotin is not licensed in this indication in children
  12. A maximum of 16 cycles of brentuximab may be administered per patient
  13. Brentuximab will be otherwise used as set out in its Summary of Product Characteristics

NHS funded From: 02 January 2018

Additional information

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CDF Managed Access: NA

NICE Technology Appraisal: TA478 (04 October 2017)

Current Form Version

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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.

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