For information, the company have announced that the Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Non squamous Non-Small Cell Lung Cancer did not meet its primary endpoint and therefore they will no longer 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 | STA Standard |
| ID number | 4028 |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 01 May 2024 | Suspended. For information, the company have announced that the Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Non squamous Non-Small Cell Lung Cancer did not meet its primary endpoint and therefore they will no longer 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. |
| 18 October 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 during early August 2024 when we will write to you about how you can get involved. |
| 10 August 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 during early January 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early March 2024. |
For further information on our processes and methods, please see our CHTE processes and methods manual