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Published

April 25, 2026

Pirtobrutinib monotherapy [PIR1]

Pirtobrutinib MONOTHERAPY for treating relapsed or refractory chronic lymphocytic leukaemia after a BTK inhibitor where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy will be prescribed by a consultant, or internally accredited haematology specialty trainee, specifically trained and assessed in the use of systemic anti-cancer therapy.
  2. The patient has been diagnosed with chronic lymphatic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
  3. The patient has been tested for 17p deletion and for TP53 mutation and the results are as shown below:
  • negative for both 17p deletion and TP53 mutation
  • positive for 17p deletion and negative for TP53 mutation or
  • negative for 17p deletion and positive for TP53 mutation or
  • positive for both 17p deletion and TP53 mutation
  1. The patient has symptomatic disease which requires systemic therapy.
  2. The patient has previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
  3. Retreatment with a covalent BTK inhibitor (including after fixed-duration regimens) is not clinically appropriate for this patient.
  4. The patient has an ECOG performance status of 0 or 1 or 2.
  5. Pirtobrutinib is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever occurs first.
  6. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment with pirtobrutinib is recommenced.
  7. Pirtobrutinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 20 April 2026

Additional information

Form version: -

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

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The data on this page was produced using version 1.394 of the CDF list, downloaded from NHS England’s website on 24 April 2026 at 18:00.

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Citation

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For attribution, please cite this work as:
<<<FULL TITLE>>>. Chemotherapy Updates. https://updates.chemo.org.uk/CDF_Forms/PIR1.html
 

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