For information, the company have announced that the topline overall survival data from the confirmatory phase 3HERTHENA-Lung02 trial (NCT05338970) did not reach statistical significance for Patritumab deruxtecan for treating EGFR mutation-positive advanced non-small-cell lung cancer after 1 or 2 tyrosine kinase inhibitor treatment and therefore they will no longer be pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) 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.
- Status:
- Suspended
- Technology type:
- Medicine
- Decision:
- Selected
- Reason for decision:
- Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
- Process:
- STA Standard
- ID number:
- 6467
Project Team
- Project lead
- Emily Richards
Email enquiries
If you have any queries please email topic.selection@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 09 October 2025 | Suspended. For information, the company have announced that the topline overall survival data from the confirmatory phase 3HERTHENA-Lung02 trial (NCT05338970) did not reach statistical significance for Patritumab deruxtecan for treating EGFR mutation-positive advanced non-small-cell lung cancer after 1 or 2 tyrosine kinase inhibitor treatment and therefore they will no longer be pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) 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. |
| 12 December 2024 | Referral |
| 12 July 2024 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
| 12 July 2024 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual