For information, the company have announced that 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 5103

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Timeline

Key events during the development of the guidance:

Date Update
01 March 2023 Suspended. For information, the company have announced that 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.
25 November 2022 As you will be aware, the Department for Health & Social Care has asked NICE to conduct an appraisal of Pembrolizumab with enzalutamide within its marketing authorisation for treating metastatic hormone-relapsed prostate cancer. Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin in early August 2023 when we will write to you about how you can get involved.
04 May 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
30 March 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
30 March 2022 Topic selection

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