Belantamab mafodotin for treating relapsed or refractory multiple myeloma after 4 or more therapies [ID2701]
Discontinued
Reference number: GID-TA10568
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 NICE is therefore withdrawing the Final Draft Guidance and the appraisal will be paused until NICE has received the MHRA’s decision.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).