Venetoclax in combination with obinutuzumab [VEN6]

For the treatment of patients with previously untreated chronic lymphatic leukaemia in whom chemotherapy with the combinations of either FCR or BR would otherwise have been UNSUITABLE where the following criteria have been met:

  1. This application for venetoclax plus obinutuzumab 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 (CLL) or small lymphocytic lymphoma (SLL).
  3. The patient has been tested for 17p deletion and the result is negative.
  4. The patient has been tested for TP53 mutation and the result is negative.
  5. The patient has symptomatic disease which requires systemic therapy.
  6. The patient has not received any previous systemic therapy for CLL/SLL.
  7. The patient has a performance status of 0 or 1 or 2.
  8. In the absence of this venetoclax plus obinutuzumab treatment option, the patient would otherwise have been considered to have been UNSUITABLE for treatment with the combination of fludarabine, cyclophosphamide and rituximab (FCR) or the combination of bendamustine and rituximab (BR).
  9. Venetoclax will be given in combination with obinutuzumab and that the venetoclax dose titration schedule will only be commenced after the patient has received the first 3 doses of obinutuzumab in cycle 1 (on days 1±2, 8 and 15) i.e. the venetoclax dose titration schedule is planned to commence on cycle 1 day 22 and be completed on cycle 2 day 28.
  10. 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. The maximum treatment duration of venetoclax in this indication is until day 28 of the 12th cycle of treatment i.e. the maximum duration of venetoclax treatment is for 45 weeks, consisting of 1 week from cycle 1 day 22 followed by 11 cycles of 4-weekly cycles of venetoclax in cycles 2-12.
  3. The treatment duration of obinutuzumab is for a maximum of 6 cycles of obinutuzumab.
  4. Venetoclax is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment or for the maximum treatment duration of 12 cycles (as measured above), whichever of these events is the sooner.
  5. A formal medical review as to whether treatment with venetoclax in combination with obinutuzumab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  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, including as appropriate if the patient had an extended break on account of Covid-19.
  7. Venetoclax and obinutuzumab will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

[NHS funded]{.badge .rounded-pill .bg-success} From: 09 March 2021

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NICE Technology Appraisal: TA663 (09 December 2021)

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