The US Food and Drug Administration (FDA) has approved belantamab mafodotin (blenrep) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.
The approval is based on the DREAMM-7 study, a phase 3, open-label, randomized, controlled trial, which previously demonstrated a significant progression-free survival benefit with blenrep compared with daratumumab, bortezomib, and dexamethasone.
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% 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 (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, according to GSK, the manufacturer of the therapy.
“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,” Sagar Lonial, MD, FACP, said in a press release from GSK. “This approval marks an important advance in the US relapsed/refractory treatment landscape.”
