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

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