FDA panel votes in favor of belantamab mafodotin for relapsed/refractory myeloma
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in favor of monotherapy treatment with belantamab mafodotin for patients with relapsed or refractory multiple myeloma concluding that the benefits outweigh potential risks, according to a press release.
Adverse events, including keratopathy were noted in a lower dose and higher dose group during the trial. Keratopathy can lead to dry eyes, blurry vision and vision loss.
“It seems clear that this is an active agent,” said ODAC chairperson Philip C. Hoffman, MD, a professor of medicine at University of Chicago Medicine during the hearing. “The toxicity is certainly not life threatening; in many instances, it isn’t even comfort threatening, though evident on examinations. I do think patients are probably willing to take this risk, and the mitigation strategy that the company has outlined for thorough exams before each dosing, a grading system, and so on, addresses the concerns.”
The bases for the Biologics License Application (BLA) comes from the 6-month primary results of a phase 2 study of heavily pre-treated patients with actively progressing multiple myeloma treated with belantamab mafodotin which demonstrated clinically meaningful response rates. Results were published in The Lancet Oncology.
Belantamab mafodotin was granted FDA breakthrough therapy designation in 2017 and priority review designator for the BLA in 2020.
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