Venetoclax in combination with azacitidine [VEN8]
For untreated adult acute myeloid leukaemia in patients unsuitable for intensive chemotherapy where the following criteria have been met:
- This application is being made by and the first cycle of systemic anti-cancer therapy with venetoclax plus azacitidine will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti- cancer therapy.
- The patient has newly diagnosed acute myeloid leukaemia (AML).
- The patient has had/is having molecular analysis performed. Please mark below the somatic mutation found:
- no analysis is being performed
- not yet available
- IDH1 or IDH2
- FLT3 ITD or TKD
- NPM1
- TP53
- another mutation
- The patient has previously untreated de novo AML or previously untreated secondary AML.
- de novo AML
- secondary AML
- The most recent bone marrow blast count is:
- 20% to <30% blasts
- 30% to <50% blasts
- 50% or more blasts
- Standard intensive chemotherapy is unsuitable for this patient. Please mark below the dominant reason as to why this patient is unsuitable for intensive chemotherapy:
- age
- fitness
- significant comorbidity or comorbidities1.
- The patient is fit for treatment with venetoclax plus azacitidine and has an ECOG performance status (PS) of 0-3.
- The patient has been prospectively assessed for the risk of the development of tumour lysis syndrome with venetoclax and that appropriate risk mitigation strategies have been put in place.
- The patient has been assessed specifically for potential drug interactions with venetoclax as set out in sections 4.2 and 4.5 of venetoclax’s Summary of Product Characteristics.
- Antifungal prophylaxis with posaconazole or voriconazole is to be given to this patient (unless there is intolerance of such antifungal prophylaxis) and thus the dosing of venetoclax has taken this drug interaction into account with the maximum venetoclax daily dose prescribed of 100mg as set out in Table 7 in section 4.2 of the Summary of Product Characteristics for venetoclax. Note: if the patient develops toxicities to posaconazole and voriconazole such that these anti-fungal agents are discontinued, venetoclax dosing at a maximum daily dose of 400mg is funded. Note: for patients in the BioDrive AFS trial (NIHR trial ID 132674) who are randomised to the intervention biomarker arm, the requirement for antifungal prophylaxis with posaconazole or voriconazole is waived and venetoclax dosing at a maximum daily dose of 400mg is funded.
- Venetoclax will be given in combination with azacitidine.
- The prescribing clinician has given consideration to the dosing schedule of venetoclax in cycle 2 onwards being for 14 days of each 28 day cycle as this was the clinical expert submission to NICE that venetoclax treatment schedule durations would usually be for 14 days from cycle 2 onwards and thus this level of dose intensity was incorporated into the economic modelling (see section 3.8 of the NICE venetoclax FAD ID1564).
- Venetoclax will be continued until disease progression or unacceptable toxicity or withdrawal of patient consent or an elective decision to discontinue treatment consequent to a sustained complete remission to therapy. Note: if venetoclax is stopped for any of the above reasons, no further venetoclax can be prescribed.
- A formal medical review as to whether treatment with venetoclax should continue will occur at least by the end of the second cycle of treatment.
- Where a treatment break of more than 10 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 COVID 19.
- Venetoclax will be otherwise used as set out in their respective Summaries of Product Characteristics (SPC).
NHS funded From: 03 May 2022
Additional information
Current Form Version
Note
The data on this page was produced using version 1.341 of the CDF list, downloaded from an archive of NHS England’s website on 11 January 2025 at 21:05.
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.