On November 22, 2022, GSK announced it has initiated the process for withdrawal of the U.S. marketing authorization for Blenrep (belantamab mafadotin-blmf) following the request of the U.S Food and Drug administration (FDA). This request was based upon the previously announced outcome of the DREAMM-3 phase III confirmatory trial which did not meet the requirements of the FDA Accelerated Approval regulations .
The DREAMM-3 trial was an open label randomized head-head superiority trial evaluating the efficacy and safety of single agent belantamab mafadfotin-blmf compared to pomalidomide in combination with low-dose dexamethasone (PomDex) in patients with RRMM. The primary end point was progression free survival (PFS — a measure of length of remission) and belantamab mafadfotin-blmf did not meet the requisite superiority test which was part of the Accelerated Approval requirement .
Transition to Compassionate Use Program
The commercial Blenrep product will continue to be available for a short period of time (probably a few weeks) until the U.S. withdrawal process is completed. Patients already receiving Blenrep and enrolled in the REMS (Risk Evaluation and Mitigation Strategy) program will have the option to enroll in a compassionate use program to continue access to treatment. Further information on how to enroll patients into the compassionate use program will be provided directly to REMS enrolled prescribers.
Patients currently being treated with Blenrep should consult with their healthcare provider to obtain more information.
Additional DREAMM Trials
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 are anticipated in the first half of 2023 and will be shared with health authorities and inform future regulatory pathways .
The IMF will keep patients informed of any new developments as they may emerge.