For information, the company have announced that the pivotal trial did not meet its primary endpoint 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 TA
ID number 5109

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Timeline

Key events during the development of the guidance:

Date Update
12 October 2023 Suspended. For information, the company have announced that the pivotal trial did not meet its primary endpoint 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.
28 March 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Pembrolizumab with lenvatinib for treating EGFR, ALK or ROS1-negative metastatic non-small-cell lung cancer after a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy have been revised. It is anticipated that the appraisal will begin in mid-May 2024 when we will write to you about how you can get involved.
11 January 2023 Please note that following on from advice received from the company the timelines for this appraisal have been revised. Therefore, we now anticipate that the appraisal will begin in mid-June 2024 when we will write to you about how you can get involved.
14 April 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

For further information on our processes and methods, please see our CHTE processes and methods manual