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The new approval completes a surprise turnaround for Blenrep, which was initially cleared in 2020 but pulled from the market only two years later.
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The Food and Drug Administration has approved GSK’s multiple myeloma drug Blenrep, officially ending the hiatus of a medication pulled from the U.S. market three years ago.
Yet the agency on Thursday issued a mixed decision in clearing the drug’s return. It approved Blenrep’s use alongside one regimen involving another myeloma medicine, Velcade, but not in combination with another therapy called Pomalyst. It also cleared Blenrep in people whose multiple myeloma has returned, or hasn’t responded, after at least two prior lines of therapy, instead of one, as GSK had requested.
Still, in a statement, GSK Chief Scientific Officer Tony Wood referred to the decision as a “significant milestone.” Wood added that “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.”
The clearance completes a turnaround for Blenrep, which was initially approved in 2020 but traveled an unusual path since.
Blenrep was the first marketed multiple myeloma medicine to target BCMA, a protein universally found on malignant cells. But it was also commonly associated with a kind of eye toxicity, and quickly followed to market by several, more effective BCMA-targeting cell therapies and antibody drugs. GSK struggled to grow market share and, in 2022, Blenrep failed a trial meant to confirm its benefits . GSK pulled it from the market shortly thereafter.
GSK didn’t give up on Blenrep altogether, though. It kept testing the drug in earlier lines of care and alongside other standard myeloma drugs, rather than as a monotherapy. In two key studies , titled DREAMM-7 and DREAMM-8, those regimens outperformed Velcade and another widely used medication, Darzalex, on measures of disease progression.
Those findings underscored approvals in the U.K. , Europe and Japan. But a clearance in the U.S. has proven more challenging. In July, a panel of FDA advisers voted that data from GSK’s two trials didn’t show a favorable benefit-risk balance . In briefing documents ahead of that meeting, the agency also outlined concerns around Blenrep’s dosing and toxicity. Days later, the FDA delayed an approval verdict by three months.
The clearance issued Thursday was based on DREAMM-7, in which a Blenrep-Velcade regimen cut the risk of death in half and tripled median progression-free survival compared to a commonly used three-drug regimen. While GSK’s drug will face even stronger competition than before — cell therapies are now used earlier in a patient’s treatment course, and multiple bispecific drugs are available, too — doctors are also better able to manage its side effects through dose reductions and eye drops.
In GSK’s statement, Wood noted how Blenrep is the only BCMA-targeting drug that can be administered across all healthcare settings, such as the community centers where most multiple myeloma patients receive care.
Clarification: The story updated to clarify that Blenrep is the only BCMA therapy administered across all healthcare settings.
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