To appraise the clinical and cost effectiveness of depatuxizumab mafodotin within its marketing authorisation for treating recurrent EGFR-amplified glioblastoma.
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
Process STA pre-2018
ID number 1244

Project Team

Project lead Michelle Adhemar

Email enquiries

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 how we develop guidance, please see our page about NICE technology appraisal guidance