Suggested remit - To appraise the clinical and cost effectiveness of pembrolizumab with chemotherapy within its marketing authorisation for treating advanced or metastatic urothelial cancer
Topic is suspended
 
Status Suspended
Process STA 2018
ID number 1545

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
06 July 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of pembrolizumab with chemotherapy for treating advanced or metastatic urothelial cancer. For information, the company have announced that the Phase 3 KEYNOTE-361 trial evaluating pembrolizumab in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy and that company have no plans to submit for a Marketing Authorisation for 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 if the situation changes.
06 July 2020 Suspended. Topic is suspended
11 September 2019 The Department for Health and Social Care has asked NICE to carry out an appraisal of pembrolizumab within its marketing authorisation for treating advanced or metastatic urothelial cancer (with chemotherapy). Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations and further information regarding the scheduling of this appraisal will be available in due course.
10 June 2019 The National Institute for Health and Care Excellence (NICE) has been asked to consider an appraisal of pembrolizumab with chemotherapy for treating advanced or metastatic urothelial cancer. We invited stakeholders to respond to a written consultation on the draft scope for this appraisal which closed on 16 May 2019. On receiving updated regulatory timing information from the company that is developing pembrolizumab, NICE has agreed that holding a scoping exercise at this time would not be appropriate. The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause. If you have any comments or concerns please contact the project manager for this proposed appraisal Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk)
15 April 2019 - 16 May 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
17 October 2018 In progress. Topic referred

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