Venetoclax with a hypomethylating agent or low dose cytarabine for untreated acute myeloid leukaemia unsuitable for intensive chemotherapy

Venetoclax with a hypomethylating agent or low dose cytarabine for untreated acute myeloid leukaemia unsuitable for intensive chemotherapy

The aim of this project, which has been commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, is to review the submission received from AbbVie on the clinical and cost-effectiveness evidence of venetoclax for treating acute myeloid leukaemia unsuitable for intensive chemotherapy.

The main source of clinical effectiveness evidence submitted by the company consists of two phase III randomised controlled trials that provide evidence for the efficacy and safety of venetoclax in combination with azacytidine or low-dose cytarabine (VIALE-A and VIALE-C) for newly diagnosed adult patients with acute myeloid leukaemia who are treatment naïve and ineligible to standard treatment with intensive chemotherapy.

The Aberdeen HTA Group acts as the Evidence Review Group (ERG) for this project and provides an independent critique of the clinical and cost-effectiveness evidence submitted by the company. Based on the findings of the company submission and of the ERG’s critique, NICE will release appropriate clinical guidance.

For more information see https://www.nice.org.uk/guidance/indevelopment/gid-ta10478

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Status

Completed