Nov 16 The company have advised that the pivotal study (Checkmate 026) failed to reach its primary end point and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme.
| Status | Discontinued |
| Decision | Selected |
| Process | TA |
| ID number | 1088 |
Project Team
| Project lead | Michelle Adhemar |
Email enquiries
- If you have any queries please email scopingta@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 19 January 2023 | Discontinued. Nov 16 The company have advised that the pivotal study (Checkmate 026) failed to reach its primary end point and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme. |
| 23 January 2017 | Suspended. Please be advised that the Department of Health has asked us to carry out a Single Technology Appraisal of nivolumab monotherapy within its marketing authorisation for non-small-cell lung cancer. However, the company have advised that the pivotal study (Checkmate 026) failed to reach its primary end point and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred to the Institute we will continue to monitor any development and will update interested parties if the situation changes. |
For further information on our processes and methods, please see our CHTE processes and methods manual