Suggested remit: To appraise the clinical and cost effectiveness of zolbetuximab with chemotherapy within its marketing authorisation for untreated claudin 18.2 positive HER2 negative unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma.
 
Status In progress
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Further information DHSC referral received
Process STA Standard
ID number 5123

Project Team

Project lead Jennifer Upton

Email enquiries

External Assessment Group Kleijnen Systematic Reviews Ltd

Stakeholders

Companies sponsors Astellas Pharma Ltd
Others Department of Health and Social Care
  NHS England
Patient carer groups OG Support
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Bristol-Myers Squibb
  MSD
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary (BNF)
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium (SMC)
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
07 October 2024 Unfortunately, for operational reasons, NICE is unable to proceed with next week’s committee discussion of zolbetuximab with chemotherapy for untreated claudin 18.2-positive HER2 negative unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma.We will update about rescheduling this discussion
02 September 2024 - 27 September 2024 Draft guidance
13 August 2024 Committee meeting: 1
13 August 2024 Declaration of interests
16 January 2024 Invitation to participate
23 November 2023 - 21 December 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 5123
23 March 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Zolbetuximab with chemotherapy for untreated CLDN 18.2-positive HER2 negative unresectable advanced gastric or gastro-oesophageal junction cancer have been revised. It is anticipated that the appraisal will begin in early-August 2023 when we will write to you about how you can get involved.
07 July 2022 In progress

For further information on our processes and methods, please see our CHTE processes and methods manual