On 27 June 2018, the company notified the Committee of Medicinal Products for Human Use (CHMP) that it was withdrawing its application to extend the license of nivolumab in the treatment of previously treated gastric or gastro-oesophageal junction cancer. Consequently this appraisal has been suspended. We will continue to monitor any developments and will update interested parties if the situation changes.
 
Status Suspended
Process STA pre-2018
ID number 1118

Project Team

Project lead Thomas Feist

Email enquiries

Evidence Review Group / Assessment Group BMJ-TAG

Consultees

Companies sponsors Bristol-Myers Squibb

Commentators

General commentators Healthcare Improvement Scotland

Timeline

Key events during the development of the guidance:

Date Update
28 November 2018 Suspended, On 27 June 2018, the company notified the Committee of Medicinal Products for Human Use (CHMP) that it was withdrawing its application to extend the license of nivolumab in the treatment of previously treated gastric or gastro-oesophageal junction cancer. Consequently this appraisal has been suspended. We will continue to monitor any developments and will update interested parties if the situation changes.
03 July 2018 Following an update from the company, the committee meeting scheduled for 19 July 2018 has been postponed. We will provide a further update on the scheduling of this appraisal in due course.
26 April 2018 Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, the committee discussion will now take place in July 2018.
02 March 2018 NICE has decided to reschedule this appraisal to align with the company’s latest regulatory expectations. The first committee discussion and will now take place on 22 May 2018.
21 June 2017 Following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, the deadline for submissions is now expected in approximately late November 2017.
05 May 2017 Invitation to participate
26 January 2017 - 23 February 2017 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