Suggested remit - To appraise the clinical and cost effectiveness of pembrolizumab within its marketing authorisation for previously treated metastatic triple negative breast.
As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for previously treated triple-negative breast cancer. However, following on from information received from the company regarding the recent results of the KEYNOTE-119 clinical trial to support this indication and that they did not meet the pre-specified primary endpoint, NICE has decided to suspend this appraisal and the timelines remain to be confirmed. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
 
Status Suspended
Process STA 2018
ID number 1246

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
08 July 2019 Suspended, As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for previously treated triple-negative breast cancer. However, following on from information received from the company regarding the recent results of the KEYNOTE-119 clinical trial to support this indication and that they did not meet the pre-specified primary endpoint, NICE has decided to suspend this appraisal and the timelines remain to be confirmed. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
26 September 2018 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for previously treated oesophageal or gastro-oesophageal junction cancer. Please note that the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-January 2019
26 September 2018 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab for previously treated oesophageal or gastro-oesophageal junction cancer. Please note that the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in mid-January 2019
31 January 2018 - 28 February 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
31 January 2018 In progress, In progress

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance