This is the pharmaceutical Joint Assessment PTJA16 – Venetoclax with a hypomethylating agent fort he treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. In June, 2021, the European Commission granted marketing authorisation for Venclyxto® (venetoclax) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. This Joint Assessment aims to compare the clinical effectiveness and safety of venetoclax in the target patient populations with relevant comparators according to the national requirements of EUnetHTA partners.
Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by AbbVie), and the Core Submission Dossier prepared by AbbVie, the Marketing Authorisation Holder of venetoclax.
A revised version of the assessment report originally posted on 08/07/2021 was published on 03/09/2021. An error was identified on 31/08/2021 regarding the risk ratio in the GRADE-table for Treatment discontinuation due to adverse events. In addition the authoring team corrected the table of summary of findings for venetoclax + azacitidine versus azacitidine alone in AML according to the GRADE approach. For further details please see the version history table in the assessment report.
For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl
PTJA16 – Final Project Plan
PTJA16 – Final Assessment Report
PTJA16 – MAH Core Submission Dossier
PTJA16 – External Comments – Factual Accuracy Check MAH
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