On November 22, 2022, GSK announced the market withdrawal of Blenrep (belantamab mafodotin-blmf) following the request of the FDA. This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations. There are additional DREAMM trials ongoing, including DREAMM-7 and DREAMM-8. These trials are evaluating belantamab mafodotin-blmf in combination with novel therapies. Results will be shared with health authorities and inform future regulatory pathways .
On November 22, 2022, GSK announced the market withdrawal of Blenrep (belantamab mafodotin-blmf) following the request of the FDA. This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
There are additional DREAMM trials ongoing, including DREAMM-7 and DREAMM-8. These trials are evaluating belantamab mafodotin-blmf in combination with novel therapies. Results will be shared with health authorities and inform future regulatory pathways .