Belantamab Mafodotin is an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity (ADCC). Belantamab Mafodotin is currently FDA approved for use in multiple myeloma patients who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. It is investigational in all other uses. Patients can click here to locate providers of Belantamab Mafodotin (BLENREP®).
On November 22, 2022, GSK announced that it has initiated the process for withdrawal of the US marketing authorization for Blenrep following the request of the US Food and Drug Administration (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 US FDA Accelerated Approval regulations. Learn More
View all active clinical trials around the US.
The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.
The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.
The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.
The following is a listing of clinical trials for patients with Smoldering Myeloma.
February 07, 2024
In the primary endpoint of progression-free survival (PFS), a statistically significant and clinically meaningful improvement was observed with the belantamab mafodotin combination (n=243), showing a 59% reduction in the risk of disease progression or death (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001) compared to the daratumumab combination (n=251). With a median follow-up of 28.2 months, the median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with the belantamab mafodotin combination compared to 13.4 months (11.1-17.5) in the daratumumab combination. The PFS effect was observed across all prespecified subgroups, including those who were refractory to lenalidomide and those with high-risk cytogenetics. The safety and tolerability profile of the belantamab mafodotin combination was consistent with the known profile of the individual agents.
Patients can locate providers of Belantamab Mafodotin (BLENREP®) based on location/zip code.
GSK recognises that there may be circumstances when it is appropriate for Healthcare Professionals to give their patients Investigational medicines to treat life threatening or seriously debilitating diseases/conditions where no satisfactory alternatives exist.