For information, the company have announced that abemacicilib did not reach its primary endpoint in the CYCLONE-2 study and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication 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 6230

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Timeline

Key events during the development of the guidance:

Date Update
21 March 2024 Suspended. For information, the company have announced that abemacicilib did not reach its primary endpoint in the CYCLONE-2 study and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication 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.
19 January 2023 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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