FDA Approves Blenrep Plus Velcade/Dexamethasone For R/R Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with Velcade (bortezomib) and dexamethasone (altogether referred to as BVd) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.

The approval was announced in a news release issued by GSK plc, the manufacturer of Blenrep.

The approval, according to the news release, was supported by data from the phase 3 DREAMM-7 trial, which showed that in patients who had two or more prior lines of therapy including a PI and an IMID, BVd was associated with a 51% reduction in the risk of death and a tripled median progression-free survival (PFS) of 31.3 months versus 10.4 months for a daratumumab-based triplet therapy (DVd). According to the news release, the safety and tolerability profiles of the combination regimen were found to be consistent with the known profiles of the individual agents.

“Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to U.S. patients,” Tony Wood, chief scientific officer of GSK, said in a statement included in the news release. “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.”

Notably, Blenrep’s approval marks the first BCMA-targeting agent that can be administered in community care settings.

“As the only anti-BCMA agent that can be administered across healthcare settings, including in community centers where 70% of patients receive care, Blenrep fulfills a major patient need,” said Wood. “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.” 

Dr. Sagar Lonial, chief medical officer at Winship Cancer Institute of Emory University in Atlanta and chair of Emory’s Department of Hematology and Medical Oncology, also commented on the agent’s approval.

“With the approval of Blenrep, we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited,” said Lonial. “This approval marks an important advance in the U.S. relapsed/refractory treatment landscape.”

Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation and the Multiple Myeloma Research Consortium, commented on the approval in the news release as well.

“The reality for most patients with multiple myeloma is a relentless cycle of remission and relapse as their disease becomes refractory to treatments,” said Andreini. “Patients urgently need more effective treatment options that can offer more quality time with their loved ones. We see the potential for Blenrep in combination to help patients achieve this.”

GSK, according to the news release, is furthering the DREAMM clinical program to demonstrate the potential benefit of Blenrep in earlier lines of treatment, with follow-up continuing for overall survival in the DREAMM-7 and DREAMM-8 clinical trials and data expected in early 2028 that includes patients who have received one prior line of therapy. Furthermore, the phase 3 DREAMM-10 trial of newly-diagnosed, transplant-ineligible patients — a patient population that makes up more than 70% of patients starting therapy — was initiated in late 2024.

Blenrep is an antibody-drug conjugate, a substance that, according to the National Cancer Institute’s website, is made up of a monoclonal antibody chemically linked to a drug. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells, and the linked drug enters these cells and kills them without harming other cells.

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References:

1. “Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma,” news release; https://www.gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/
2. “Antibody-drug conjugate,” National Cancer Institute; https://www.cancer.gov/publications/dictionaries/cancer-terms/def/antibody-drug-conjugate