For information, the company have announced that CheckMate 7DX did not meet its primary endpoints and the study will be discontinued, 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 |
| Decision | Selected |
| Process | TA |
| ID number | 4048 |
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 30 August 2023 | Suspended. For information, the company have announced that CheckMate 7DX did not meet its primary endpoints and the study will be discontinued, 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. |
| 12 December 2022 | As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of Nivolumab with docetaxel for treating hormone-relapsed advanced prostate cancer after 1 or 2 hormonal therapies. Please note that following on from advice received from the company the timelines for this appraisal are to be confirmed. The appraisal will be rescheduled to align with latest regulatory expectations and an update on the revised timelines will be provided when further information is available. |
For further information on our processes and methods, please see our CHTE processes and methods manual