For information, the company have announced that the Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine for the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) has not met the primary endpoint and as such, they will no longer be pursuing a Marketing Authorisation variation in this indication in the UK at this time.    Therefore, NICE has decided to suspend this appraisal from its current work programme.    As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes. 

Status:
Suspended
Technology type:
Medicine
Decision:
Selected
Reason for decision:
Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process:
STA Standard
ID number:
6314

Email enquiries

If you have any queries please email [email protected]

Timeline

Key events during the development of the guidance:

Date Update
18 September 2025 Suspended. For information, the company have announced that the Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine for the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) has not met the primary endpoint and as such, they will no longer be pursuing a Marketing Authorisation variation in this indication in the UK at this time.    Therefore, NICE has decided to suspend this appraisal from its current work programme.    As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes. 
09 February 2024 In progress. In progress
14 June 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

For further information on our processes and methods, please see our CHTE processes and methods manual