Suggested remit - to appraise the clinical and cost effectiveness of nivolumab within its marketing authorisation for treating small-cell lung cancer after platinum-based chemotherapy
Referred 05/12/2016
 
Status Suspended
Process STA 2018
ID number 1126

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
16 September 2019 The Department for Health and Social Care has asked NICE to carry out an appraisal of nivolumab for treating small-cell lung cancer after platinum-based chemotherapy. For information, the company have advised that 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.
16 September 2019 Suspended, Referred 05/12/2016
29 November 2018 As you are aware the Department for Health and Social Care has asked NICE to carry out an appraisal of nivolumab for treating small-cell lung cancer after platinum-based chemotherapy. However, the company have advised that the Phase III CheckMate -331 Study did not meet its primary endpoint of Overall Survival with Opdivo versus Chemotherapy in patients with previously treated relapsed small cell lung cancer. Therefore, the timelines for this appraisal are to be confirmed whilst NICE continues to liaise with company on the next steps. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes
24 September 2018 - 22 October 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
05 December 2016 Referral

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