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
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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