Suggested remit - To appraise the clinical and cost effectiveness of rovalpituzumab tesirine within its marketing authorisation for treating small-cell lung cancer after 2 therapies.
The Department for Health and Social Care has asked NICE to conduct an appraisal of rovalpituzumab tesirine for treating small-cell lung cancer after 2 therapies. However, the company have advised that they will not be pursuing a Marketing Authorisation Application for rovalpituzumab tesirine from the European Medicines Authority for this indication at this time. This decision does not impact other Rova-T clinical studies. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred, NICE will continue to monitor the situation and update interested parties if the situation changes.
 
Status Suspended
Process STA 2018
ID number 1288

Project Team

Project lead Emily Richards

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
11 March 2019 Suspended, The Department for Health and Social Care has asked NICE to conduct an appraisal of rovalpituzumab tesirine for treating small-cell lung cancer after 2 therapies. However, the company have advised that they will not be pursuing a Marketing Authorisation Application for rovalpituzumab tesirine from the European Medicines Authority for this indication at this time. This decision does not impact other Rova-T clinical studies. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred, NICE will continue to monitor the situation and update interested parties if the situation changes.
08 June 2018 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of rovalpituzumab tesirine for treating small-cell lung cancer after 2 therapies. Following on from an update from the company, the timelines for this appraisal are to be confirmed. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties as and when the situation changes.
06 February 2018 - 06 March 2018 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
24 April 2017 In progress, DH Referral Received

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