Blenrep (belantamab mafodotine), an antibody-drug conjugate given speedy approvals in both the US and the EU in 2020, and later withdrawn for insufficient efficacy, has won approval for a new market entry in the UK on the basis of two combination studies. The drug was developed by GSK Plc to treat patients with relapsed or refractory multiple myeloma, the third most common blood cancer globally.
“As patients with multiple myeloma increasingly receive combination therapies at diagnosis, treatment options available in the community setting that use different mechanisms like Blenrep are crucial to extending remission and ultimately survival,” Joseph Mikhael, chief medical officer at the International Myeloma Foundation, said in a prepared statement.
Blenrep’s initial approval in 2020 was as a stand-alone therapy. It received an accelerated approval from the US Food and Drug Administration and a conditional approval from the European Commission – decisions that had to be followed up with more evidence of efficacy. The marketing authorisations were withdrawn when the follow-up efficacy data fell short of what was required. The newest Blenrep formulations are combination therapies that have shown strong progression-free survival when compared with standards of care for the disease.
The MHRA approved Blenrep in combination with bortezomib (Velcade), a proteasome inhibitor, and dexamethasone, a corticosteroid, in patients who have received at least one prior therapy. The agency also approved Blenrep in combination with pomalidomide plus dexamethasone for patients who have received at least one prior therapy including lenalidomide.
The first combination was tested in the DREAMM-7 Phase 3 trial, and the second, in DREAMM-8. In the DREAMM-7 trial, the Blenrep combination nearly tripled median progression free survival compared with a combination that included daratumumab, an approved drug for multiple myeloma. In DREAMM-8 the median progression-free survival threshold had not been reached at the time of the trial’s read-out.
The original Blenrep approval carried a boxed warning about the risk of ocular toxicity. In the MHRA review, eye-related side effects were generally resolvable, GSK said. The UK company has made regulatory submissions in 14 other markets, including the US.
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