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

The Food and Drug Administration (FDA) granted a priority review to belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, according to GlaxoSmithKline.

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 three 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.

Patients demonstrated an overall response rate of 31%, 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 six months of follow-up.

No new safety signals were seen. The safety and tolerability profile were consistent with previously reported data on belantamab mafodotin, with the the three most commonly reported grade 3 or 4 side effects including keratopathy (27%), thrombocytopenia (20%) and anaemia (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, Dr. Sagar Lonial, 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.

“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.”

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