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

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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