Suggested remit: to appraise the clinical and cost effectiveness of erdafitinib within its marketing authorisation for treating metastatic or unresectable fibroblast growth factor receptor (FGFR)-positive urothelial cancer.
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 1333

Provisional Schedule

Committee meeting 06 November 2024
Expected publication 29 January 2025

Project Team

Project lead Celia Mayers

Email enquiries


Companies sponsors Johnson and Johnson Innovative Medicine
Others Department of Health and Social Care
  HS England
Patient carer groups Action Bladder Cancer UK
  Black Health Agency for Equality
  Bladder and Bowel Community
  Bladder and Bowel UK
  Cancer 52
  Cancer Black Care
  Cancer Equality
  Fight Bladder Cancer
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  Pelican Cancer Foundation
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
Professional groups Association of Cancer Physicians
  British Association of Urological Nurses
  British Association of Urological Surgeons
  British Geriatrics Society
  British Gynaecological Cancer Society
  British Institute of Radiology
  British Oncology Pharmacy Association
  British Psychosocial Oncology Society
  British Society of Urogenital Radiology
  British Society of Urogynaecology
  British Uro-Oncology Group
  Cancer Research UK
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Oncology Nursing Society
  Urology Foundation
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Bristol Myers Squibb Pharmaceuticals limited (nivolumab)
  Celgene (paclitaxel)
  Hospira UK Ltd (docetaxel, paclitaxel)
  Merck, Sharp & Dohme (pembrolizumab)
  Roche (atezolizumab)
  Seacross Pharmaceuticals (docetaxel,
  Teva UK Limited (paclitaxel
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Cochrane UK
  Cochrane Urology
  Genomics England
  Institute of Cancer Research
  MRC Clinical Trials Unit
  National Institute for Health Research


Key events during the development of the guidance:

Date Update
22 April 2024 Invitation to participate
16 January 2024 - 13 February 2024 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: ID1333
16 January 2024 In progress. Scoping commenced.
23 October 2023 Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during mid-April 2024 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately mid-June 2024.
13 December 2018 Following notification from the company, the timelines for this appraisal will be confirmed once regulatory approval timelines have been established. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties as and when the situation changes.
03 September 2018 This appraisal will be rescheduled to allow the company to include important data to be presented in their submission. This delay means that this appraisal will be removed from the NICE’s reporting targets for timeliness. In addition, through this request for delay the company accepts that this drug will not be eligible to receive interim CDF funding from the date of marketing authorisation.
06 June 2018 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of erdafitinib for treating metastatic or unresectable FGFR-positive urothelial cancer. Following on from an update from the company, the timelines for this appraisal remain 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.
28 September 2017 In progress. In progress

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