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FDA Approves Belantamab Mafodotin-blmf for R/R Multiple Myeloma

Multiple myeloma.

Belantamab mafodotin-blmf (BLENREP®, GlaxoSmithKline) was recently FDA approved for adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have previously failed four therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Approval was based on DREAMM-2 (NCT03525678), an open-label, multicenter trial that enrolled 293 patients with R/R MM with disease progression after three or more lines of prior therapy and who were refractory to immunomodulatory drugs, proteasome inhibitors, and an anti-CD38 monoclonal antibody.

Patients were randomly assigned in a 1:1 ratio to receive either 2.5 mg/kg or 3.4 mg/kg of intravenous belantamab mafodotin-blmf every 3 weeks on day 1 of each cycle until disease progression or unacceptable toxicity. Primary end points were overall response rate (ORR) and response duration, as assessed by an independent review committee using the International Myeloma Working Group uniform response criteria.

The ORR was found to be 31%, and 73% of patients had a response duration greater than or equal to 6 months. These results were found in patients who took the recommended dose of belantamab mafodotin-blmf, which is 2.5 mg/kg once every 3 weeks as an intravenous infusion to be administered for 30 minutes.

Sagar Lonial, MD, principal investigator of DREAMM-2, and Chief Medical Officer at Winship Cancer Institute of Emory University, commented on the study results, "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. 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."

Belantamab mafodotin-blmf causes changes in the corneal epithelium which results in alterations in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes. Ophthalmic exams at baseline, prior to each dose, and immediately for worsening symptoms is necessary.

Other side effects that occurred in greater than 20% of patients included keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.

For More Information

Blenrep® (belantamab mafodotin-blmf) prescribing information (2020). GlaxoSmithKline. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761158s000lbl.pdf

Clinicaltrials.gov (2020). A study to investigate the efficacy and safety of two doses of GSK2857916 in participants with multiple myeloma who have failed prior treatment with an anti-CD38 antibody. NLM Identifier: NCT03525678

Lonial S, Lee HC, Badros A, et al (2020). Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomized, open-label, phase 2 study. Lancet Oncol, 21(2):207-221. DOI:10.1016/S1470-2045(19)30788-0

Image Courtesy of Nephron. Licensed under CC BY-SA 3.0


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