GSK's Blenrep receives US FDA approval
By Iain Gilbert
Date: Friday 24 Oct 2025
(Sharecast News) - Drugmaker GSK said on Friday that the US Food and Drug Administration had approved its Blenrep asset in combination with bortezomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma.
GSK said the approval covers patients who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and was based on data from the pivotal phase III DREAMM-7 trial.
In patients who had two or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, Blenrep in combination demonstrated a clinically meaningful 51% reduction in the risk of death and a tripled median progression-free survival of 31.3 months, versus 10.4 months for a daratumumab-based triplet.
GSK also noted that the safety and tolerability profiles of the Blenrep combination were "broadly consistent" with the known profiles of the individual agents.
Chief scientific officer Tony Wood said: "Today's FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients.
"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."
Reporting by Iain Gilbert at Sharecast.com
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