Suggested remit - To appraise the clinical and cost effectiveness of durvalumab within its marketing authorisation for untreated metastatic urothelial cancer
Following on from information provided to NICE by the company in June 2020, the appraisal of Durvalumab for untreated metastatic urothelial cancer [ID1169] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
 
Status Discontinued
Technology type Medicine
Decision Selected
Process TA
ID number 1169

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Timeline

Key events during the development of the guidance:

Date Update
23 November 2022 Discontinued. Following on from information provided to NICE by the company in June 2020, the appraisal of Durvalumab for untreated metastatic urothelial cancer [ID1169] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
30 June 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of durvalumab for untreated metastatic urothelial cancer [ID1169]. 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 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
13 February 2018 In progress. Topic referred

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