FDA Approves Blenrep to Treat Relapsed/Refractory Multiple Myeloma


The Food and Drug Administration approved Blenrep to treat patients with relapsed/refractory multiple myeloma.

The Food and Drug Administration approved Blenrep (belantamab mafodotin-blmf) to treat patients with relapsed/refractory multiple myeloma who have received 4 prior therapies, according to GlaxoSmithKline.

Moreover, the agent is the first anti- B-cell maturation antigen (BCMA) therapy approved anywhere in the world.

“As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease. Blenrep is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today,” Dr. Hal Barron, chief scientific officer and president of research and development at GSK, said in a press release.

The indication, which includes patients who have received 4 prior therapies including an anti-CD38 monoclonal antibody or a proteasome inhibitor and an immunomodulatory agent, is approved under accelerated approval based on a 31% response rate in the DREAMM-2 study.

In addition, the median duration of response had not been reached at the six-month analysis. Of the 73% of patients who responded to therapy, however, their duration of response was six months or longer.

The most commonly reported side effects included keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions and fatigue.

“While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care,” principal investigator Dr. Sagar Lonial, chief medical officer at Winship Cancer Institute of Emory University in Atlanta, Georgia, and chair of the Emory Department of Hematology and Medical Oncology, said in the release.

“Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of Blenrep, the first anti-BCMA therapy, is significant for both patients and physicians alike,” he added.

Of note, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, according to the GSK release.

Check back later for what this approval means for patients with multiple myeloma.

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