Published

May 11, 2025

Venetoclax monotherapy [VEN1]

Treatment of chronic lymphatic leukaemia in the ABSENCE of 17p deletion (and absence of TP53 mutation if tested) where the following criteria have been met:

  1. This application for venetoclax plus rituximab is being made by and the first cycle of this systemic anti -cancer therapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has been diagnosed with chronic lymphatic leukaemia or small lymphocytic lymphoma that requires treatment.
  3. The patient has been tested for 17p deletion and the result is negative. If TP53 mutation has been tested, then it must be negative too.
  4. The prescribing clinician can confirm whether the patient was previously treated with chemoimmunotherapy and if so, then the patient must have had progressive disease. Please mark below which applies to this patient:
  • the patient has never received chemoimmunotherapy
  • the patient has previously been treated with chemoimmunotherapy and had progressive disease on/after such treatment
  1. The patient had progressive disease on or after treatment with a B cell receptor pathway inhibitor: a Bruton’s tyrosine kinase inhibitor (BTKi e.g. ibrutinib, acalabrutinib) and/or a PI3K inhibitor (PI3Ki e.g. idelalisib) or has a contraindication to receiving both a BTKi and a PI3Ki. Please indicate which:
  • relapse on/after a BTKi -relapse on/after a PI3Ki
  • relapse on/after both a BTKi and a PI3Ki
  • there is a contraindication to both a BTKi and a PI3Ki
  1. The number of previous lines of therapy that the patient has received:
  • 1 previous line of treatment
  • 2 previous lines of treatment
  • 3 previous lines of treatment
  • 4 or more lines of previous treatment
  1. The patient has never received venetoclax before or has been previously treated with the combination of venetoclax with an anti-CD20 antibody (obinutuzumab or rituximab) or the combination of ibrutinib plus venetoclax in which case the patient must not have progressed during such treatment with venetoclax. Please mark below whether patient has received previous venetoclax:
  • no previous treatment ever with venetoclax or
  • previous treatment with the combination of venetoclax and obinutuzumab and there was no disease progression whilst on venetoclax
  • previous treatment with the combination of venetoclax and rituximab and there was no disease progression whilst on venetoclax
  • previous treatment with the combination of ibrutinib plus venetoclax and there was no disease progression whilst on venetoclax
  1. The patient has an ECOG performance status of 0-2
  2. All of the following for the prevention and treatment of tumour lysis syndrome:
  • that the patient has been prospectively assessed for the risk of the development of tumour lysis syndrome (TLS) with venetoclax
  • that appropriate TLS risk mitigation strategies have been put in place as outlined in the updated venetoclax Summary of Product Characteristics
  • that there is a robust system in place for measuring appropriate blood chemistries both at the specified timings of blood chemistries according to TLS risk status and at the venetoclax dose levels described in Section 4.2 Table 3 of the Summary of Product Characteristics. See https://www.medicines.org.uk/emc/medicine/32650 or https://products.mhra.gov.uk/substance/?substance=VENETOCLAX
  • that there is a robust system in place for ensuring the rapid review in real time of these blood chemistry results by a senior clinician with experience in the management of TLS
  • that there is a robust system in place for the withholding of the next days dose of each scheduled dose escalation until the blood chemistry results have been confirmed as being satisfactory by a senior clinician
  1. The patient has been assessed specifically for potential drug interactions with venetoclax.
  2. Venetoclax is to be used as a single agent.
  3. Venetoclax is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
  4. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  5. Venetoclax to be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 15 July 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA796 (15 June 2022)

Current Form Version

Note

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.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.