For information, the company have announced that KEYNOTE 585 trial met one of its three primary endpoints and they will not be pursuing a Marketing Authorisation Application in 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 as and when the situation changes.
| Status | Suspended |
| Technology type | Medicine |
| Decision | Selected |
| Process | TA |
| ID number | 2696 |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 18 July 2023 | Suspended. For information, the company have announced that KEYNOTE 585 trial met one of its three primary endpoints and they will not be pursuing a Marketing Authorisation Application in 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 as and when the situation changes. |
| 16 June 2023 | Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin in early July 2024 when we will write to stakeholders about how they can get involved. The deadline for submissions is expected in approximately early September 2024. |
| 09 May 2023 | Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in late August 2023. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission. |
| 30 March 2023 | Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Pembrolizumab with chemotherapy and surgery for treating resectable gastric or gastro-oesophageal junction cancer have been revised. It is anticipated that the appraisal will begin in mid-June 2023 when we will write to you about how you can get involved. |
| 01 July 2021 - 29 July 2021 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
| 17 June 2021 | Timelines for this appraisal are to be confirmed. Further information regarding the scheduling of this appraisal will be available in due course. |
| 24 January 2020 | In progress. Topic is in progress |
For further information on our processes and methods, please see our CHTE processes and methods manual