The Department of Health has asked us to carry out a Single Technology Appraisal (STA) of nintedanib within its marketing authorisation for colorectal cancer.
The company have advised that the pivotal study failed to meet one of its co-primary end points and they will not be seeking regulatory approval from the European Medicines Authority for this indication. Therefore, NICE has decided to suspend this appraisal from its work programme.
As this appraisal has been referred, we will continue to monitor any development and will update interested parties if the situation changes
Status | Suspended |
Process | STA pre-2018 |
ID number | 1030 |
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 |
---|---|
22 November 2016 | Suspended. The Department of Health has asked us to carry out a Single Technology Appraisal (STA) of nintedanib within its marketing authorisation for colorectal cancer. The company have advised that the pivotal study failed to meet one of its co-primary end points and they will not be seeking regulatory approval from the European Medicines Authority for this indication. Therefore, NICE has decided to suspend this appraisal from its work programme. As this appraisal has been referred, we will continue to monitor any development and will update interested parties if the situation changes |
22 July 2016 | Referral |
For further information on how we develop guidance, please see our page about NICE technology appraisal guidance