GSK has received approval from the US Food and Drug Administration (FDA) for Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of multiple myeloma.
The therapy is now approved for use in adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).
Blenrep, a monoclonal antibody-drug conjugate targeting B Cell maturation antigen (BCMA), will be distributed in the US under a streamlined Risk Evaluation and Mitigation Strategy (REMS) designed to enhance patient engagement and reduce administrative burden. According to GSK, the updated REMS includes simplified patient forms, removal of duplicate checklists and improved communication between healthcare providers and eye-care specialists monitoring ocular safety.
US patients prescribed Blenrep will also have access to Together with GSK, an optional patient support programme.
The FDA approval is supported by results from the phase 3 DREAMM-7 trial – a multicentre, open-label, randomised study evaluating the efficacy and safety of Blenrep in patients with relapsed or refractory multiple myeloma.
The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival, as well as prolonged progression-free survival, compared with standard treatment.
Tony Wood, Chief Scientific Officer, GSK, said: “Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients. There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes.”
“As the only anti-BCMA agent that can be administered across healthcare settings, including in community centres where 70% of patients receive care, Blenrep fulfils a major patient need. We believe Blenrep can redefine treatment for patients with multiple myeloma in all parts of the world, and we are accelerating its development in earlier lines of therapy to support its use across all stages of this difficult-to-treat cancer.”