FDA approves Blenrep for relapsed, refractory multiple myeloma
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The FDA granted accelerated approval to belantamab mafodotin-blmf for treatment of relapsed or refractory multiple myeloma.
Belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) — an anti-B-cell maturation antigen (BCMA) therapy — is indicated for adults who received at least four prior therapies, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
“As the second most common form of blood cancer in the U.S., multiple myeloma is an incurable and devastating disease,” Hal Barron, MD, chief scientific officer and president of research and development at GlaxoSmithKline, said in a company-issued press release. “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.’’
The FDA based the approval on results of the DREAMM-2 study, which included patients with relapsed or refractory multiple myeloma who had actively progressing disease that worsened after standard treatment. Trial participants had received a median seven prior lines of treatment, were refractory to an immunomodulatory drug and a proteasome inhibitor, and were refractory and/or intolerant to an anti-CD38 antibody.
Ninety-seven patients (median age, 65 years; interquartile range, 60-70) received belantamab mafodotin-blmf dosed at 2.5 mg/kg via IV every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
Results showed an overall response rate in this group of 31% (97.5% CI, 21-43). Median duration of response had not been reached; however, 73% of responses lasted at least 6 months.
A pooled safety analysis of 218 patients treated with the agent showed 77% experienced ocular adverse events, the most common of which were keratopathy (76%), changes in visual acuity (55%), blurred vision (27%) and dry eye (19%). Other adverse events that occurred among more than 20% of patients included nausea, pyrexia, infusion-related reactions and fatigue.
“[Although] 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,” Sagar Lonial, MD, FACP, chair and professor in the department of hematology and medical oncology at Winship Cancer Institute of Emory University and a HemOnc Today Editorial Board Member, 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.”
The FDA previously granted breakthrough therapy designation to belantamab mafodotin-blmf.
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