Suggested remit: To appraise the clinical and cost effectiveness of belantamab mafodotin within its marketing authorisation for treating relapsed or refractory multiple myeloma after 4 or more therapies.
Status In progress
Technology type Medicine
Decision Selected
Process TA
ID number 2701

Project Team

Project lead Kate Moore

Email enquiries

External Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter


Companies sponsors GlaxoSmithKline (belantamab mafodotin)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Blood Cancer UK
  Myeloma UK
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Bristol Myers Squibb (pomalidomide and thalidomide)
  Janssen-Cilag (bortezomib)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research


Key events during the development of the guidance:

Date Update
19 October 2023 On 14 September 2023, a non-favourable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) was issued for the belantamab mafodotin annual renewal procedure (EMEA/H/C/004935/R/0017). The non favourable opinion means that the European Medicines Agency’s CHMP has recommended not renewing the conditional marketing authorisation for belantamab mafodotin. On 21 September 2023 and in accordance with Article 9(2) of Regulation (EC) No. 726/2004, GSK requested the re-examination of the CHMP opinion for belantamab mafodotin’s annual renewal. Following the company’s re-examination request, the Medicines and Healthcare products Regulatory Agency (MHRA), the regulator of medicines in the UK, is currently assessing the annual renewal of the GB marketing authorisation for belantamab mafodotin, as per the national procedure, and will make the decision on whether the licence is renewed in this country. NICE is therefore withdrawing the Final Draft Guidance and the appraisal will be paused until NICE has received the MHRA’s decision. This means that the appeal hearing will not proceed on 2 November but will be rescheduled in due course (if required).
07 September 2023 Appeal
14 June 2023 Committee meeting: 2
09 May 2023 - 31 May 2023 Draft guidance
13 April 2023 Committee meeting
02 August 2022 Invitation to participate
01 June 2022 - 01 July 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
01 June 2022 Scoping commenced
24 January 2020 In progress. Topic is in progress

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