Suggested Remit: To appraise the clinical and cost effectiveness of atezolizumab in combination with bevacizumab within its marketing authorisation for untreated locally advanced or metastatic renal cell carcinoma.
As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of atezolizumab for untreated advanced renal cell carcinoma. However, the company have advised NICE that based on the currently available data from the Phase III IMmotion151 trial, they will be withdrawing their application for 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. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Process STA 2018
ID number 1365

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Timeline

Key events during the development of the guidance:

Date Update
22 November 2018 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of atezolizumab for untreated advanced renal cell carcinoma. However, the company have advised NICE that based on the currently available data from the Phase III IMmotion151 trial, they will be withdrawing their application for 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. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes.
22 November 2018 Suspended, As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of atezolizumab for untreated advanced renal cell carcinoma. However, the company have advised NICE that based on the currently available data from the Phase III IMmotion151 trial, they will be withdrawing their application for 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. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties if the situation changes.
03 April 2018 - 01 May 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
05 December 2017 In progress, DH referral Received

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