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The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday authorized GSK plc’s (NYSE:GSK) Blenrep.
Blenrep is approved for the treatment of adults with multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.
This U.K. regulatory authorization marks the first in the world for Blenrep in this treatment setting.
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Efficacy results from the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma support MHRA authorization of Blenrep combinations.
These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) in DREAMM-7.
DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the Blenrep combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.
In DREAMM-7, the Blenrep combination nearly tripled median PFS versus the daratumumab-based comparator (36.6 months versus 13.4 months, respectively.
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DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months, favoring the Blenrep combination (n=243) versus the daratumumab-based comparator (n=251).
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The three-year OS rate was 74% in the Blenrep combination arm and 60% in the daratumumab combination arm.
In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached with the Blenrep combination compared to 12.7 months in the bortezomib combination.
Blenrep combinations are currently under review in 14 countries, including the U.S., with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025.
In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
Price Action: GSK stock is up 1.74% at $35.99 at the last check Thursday.