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.
 
Status Suspended
Process STA
ID number 1088

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
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 how we develop guidance, please see our page about NICE technology appraisal guidance