To appraise the clinical and cost effectiveness of pertuzumab within its marketing authorisation for untreated metastatic HER2-positive gastric or gastro-oesophageal junction cancer.
As you will be aware, the Department of Health has asked NICE to conduct a Single Technology Appraisal of pertuzumab for untreated metastatic HER2-positive gastric or gastro-oesophageal junction cancer. However, the company have advised that they will not be pursuing a licensing application for pertuzumab from the European Medicines Authority for this indication at this time. This decision is based on the results from the JACOB study, which did not meet its primary endpoint. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes
 
Status Suspended
Process STA pre-2018
ID number 1096

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
16 October 2017 Suspended, As you will be aware, the Department of Health has asked NICE to conduct a Single Technology Appraisal of pertuzumab for untreated metastatic HER2-positive gastric or gastro-oesophageal junction cancer. However, the company have advised that they will not be pursuing a licensing application for pertuzumab from the European Medicines Authority for this indication at this time. This decision is based on the results from the JACOB study, which did not meet its primary endpoint. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes
24 August 2017 - 22 September 2017 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
05 December 2016 Referral

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance