On Thursday, October 23, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of Blenrep® (belantamab mafodotin-blmf)— "a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate — with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent."
Additionally, GSK announced via a press release that the approval is supported by data from the DREAMM-7 phase III trial. “In patients who had two or more prior lines of therapy (3L+), including a PI and an IMID, Blenrep in combination demonstrated a clinically meaningful 51% reduction in the risk of death [HR 0.49, 95% confidence interval (CI): 0.32-0.76] and a tripled median progression-free survival (PFS) of 31.3 months [95% CI: 23.5-NR)] versus 10.4 months [95% CI: 7.0-13.4] for a daratumumab-based triplet (DVd) [HR 0.31, 95% CI: 0.21-0.47]. The safety and tolerability profiles of the Blenrep combination were broadly consistent with the known profiles of the individual agents,” said GSK.
IMF Scientific Advisory Board Member and Chief Medical Officer of the Winship Cancer Institute of Emory University in Atlanta, GA, Dr. Sagar Lonial said: “With the approval of Blenrep, we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited. This approval marks an important advance in the US relapsed/refractory treatment landscape.”
Because of the risk of ocular toxicity, belantamab mafodotin-blmf is available only through a Risk Evaluation and Mitigation Strategy (REMS), called the BLENREP REMS, according to the FDA.
"This updated REMS helps ensure safe and appropriate use of Blenrep while reducing paperwork and improving communication between healthcare providers and eye specialists," states GSK.
GSK also offers Together with GSK, an optional support program for all U.S. patients prescribed Blenrep.
According to the FDA, full prescribing information for Blenrep will be posted on Drugs@FDA.
"Prescribing information includes a Boxed Warning for the risk of ocular toxicity, including corneal epithelium changes resulting in vision deterioration. Among those receiving belantamab mafodotin-blmf in DREAMM-7, ocular toxicity occurred in 92% of patients, including Grade 3 or 4 in 77%, with 83% requiring dosage modification due to ocular toxicity," states the FDA.
To know more, read the full press releases from the FDA and GSK.