The Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for etirinotecan pegol intended for the treatment of advanced breast cancer with brain metastases. Consequently the first appraisal committee discussion of this topic, has been cancelled. We will continue to monitor any developments and will update interested parties if the situation changes.
 
Status Suspended
Process STA pre-2018
ID number 881

Project Team

Project lead Thomas Feist

Email enquiries

Evidence Review Group / Assessment Group BMJ Group

Timeline

Key events during the development of the guidance:

Date Update
21 April 2020 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of etirinotecan pegol for treating breast cancer with brain metastases. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the European Medicines Agency for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
25 July 2017 Suspended. The Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for etirinotecan pegol intended for the treatment of advanced breast cancer with brain metastases. Consequently the first appraisal committee discussion of this topic, has been cancelled. We will continue to monitor any developments and will update interested parties if the situation changes.
18 August 2016 Invitation to participate
02 June 2016 Draft scope documents
13 May 2016 Referral

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