Please be advised that the Department of Health has asked NICE to carry out a Single Technology Appraisal of depatuxizumab mafodotin within its marketing authorisation for treating recurrent, EGFR amplified glioblastoma.
However, the company have advised that their INTELLANCE 2 clinical study has not met its primary endpoint and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme.
| Status | Suspended |
| Decision | Selected |
| Process | STA pre-2018 |
| ID number | 1244 |
Project Team
| Project lead | Michelle Adhemar |
Email enquiries
- If you have any queries please email scopingta@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 29 January 2018 | Suspended. Please be advised that the Department of Health has asked NICE to carry out a Single Technology Appraisal of depatuxizumab mafodotin within its marketing authorisation for treating recurrent, EGFR amplified glioblastoma. However, the company have advised that their INTELLANCE 2 clinical study has not met its primary endpoint and they will not be seeking regulatory approval from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its work programme. |
| 25 September 2017 - 23 October 2017 | Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators |
| 20 October 2017 | Please note this scoping exercise has now been suspended pending confirmation of trial reporting and regulatory submission timelines. Please do not submit comments on this topic. We apologise for any inconvenience this may cause. |
For further information on our processes and methods, please see our CHTE processes and methods manual