Suggested remit - To appraise the clinical and cost effectiveness of durvalumab with tremelimumab within its marketing authorisation for untreated metastatic urothelial cancer
Topic is suspended
 
Status Suspended
Process STA 2018
ID number 1335

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
30 June 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of durvalumab with tremelimumab for untreated metastatic urothelial cancer [ID1335]. For information, the company have advised that the Phase III DANUBE trial did not meet its primary endpoint of improving overall survival versus standard of care and they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency 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.
30 June 2020 Suspended. Topic is suspended
04 April 2019 Dear Consultees and Commentators As you will be aware the Department for Health and Social Care has asked NICE to conduct an appraisal of durvalumab with tremelimumab for untreated metastatic urothelial cancer. Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations. Further information regarding the scheduling of this appraisal will be available in due course.
19 October 2018 - 16 November 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
24 April 2018 In progress. Topic referred

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