FDA Grants Priority Review to Belantamab Mafodotin for Relapsed/Refractory Myeloma


The agency granted the immunoconjugate targeting B-cell maturation antigen priority review to belantamab mafodotin for the treatment of heavily pre-treated patients with relapsed or refractory multiple myeloma.

The FDA granted a priority review to belantamab mafodotin for the treatment of heavily pre-treated patients with relapsed or refractory multiple myeloma, according to GlaxoSmithKline.1

With this, belantamab mafodotin has potential to be the first anti-BCMA treatment available to patients.

The company based is biologics license application on data from the pivotal, open-label, two-arm, phase 2 DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study — designed to evaluate belantamab mafodotin in 293 patients with relapsed or refractory multiple myeloma with disease progression after 3 or more lines of therapy and who were refractory to immunomodulatory drugs and proteasome inhibitors, and refractory or intolerant (or both) to an anti-CD38 monoclonal antibody.2

Patients demonstrated an overall response rate of 31% (97.5% CI, 20.8—42.6), with 30 of 97 patients experiencing a response to therapy. Of these responders, 18 achieved a very good partial response or better, including three patients with stringent complete or complete responses.

The median duration of response and overall survival have not been reached at 6 months of follow-up.

No new safety signals were seen. The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin, with the 3 most commonly reported grade 3 or 4 edverse events including keratopathy (27%), thrombocytopenia (20%), and anemia (20%).

“Each day in my practice, I see patients who would benefit from additional therapeutic options because their disease has advanced and is no longer responding to available treatments,” principal investigator of the study, Sagar Lonial, MD, who is also chief medical officer at Winship Cancer Institute of Emory University and chair of the Emory Department of Hematology and Medical Oncology, said in a press release.3

“In recent years, (B-cell maturation antigen [BCMA]) has become one of the most promising targets in multiple myeloma research,” he added. “The data…from DREAMM-2 not only reinforce the significance of BCMA as a potentially viable target, but also underscore the potential of belantamab mafodotin, if approved, as a practical treatment option in this patient population.”


1. GlaxoSmithKline. US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma. Available from: https://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-grants-priority-review-of-belantamab-mafodotin-for-patients-with-relapsed-or-refractory-multiple-myeloma-300990248.html?tc=eml_cleartime. Accessed on January 21, 2020.

2. Lonial S, Lee HC, Badros A. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. doi:10.1016/S1470-2045(19)30788-0.

3. GlaxoSmithKline. Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma. Available from: https://www.gsk.com/en-gb/media/press-releases/pivotal-dreamm-2-study-demonstrated-a-clinically-meaningful-overall-response-rate-with-belantamab-mafodotin-gsk2857916-for-patients-with-relapsedrefractory-multiple-myeloma. Accessed on: January 21, 2020.

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