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

Gina Columbus @ginacolumbusonc
Published: Tuesday, Jan 21, 2020

The FDA has granted a priority review designation to a biologics license application (BLA) for belantamab mafodotin as a treatment for patients with relapsed/refractory multiple myeloma who received prior therapy with an immunomodulatory drug (IMiD), a proteasome inhibitor, and an anti-CD38 antibody.1

The BLA is based on findings from the pivotal DREAMM-2 trial, which showed that belantamab mafodotin elicited an overall response rate (ORR) of 31% (97.5% CI, 20.8-42.6) in patients with relapsed/refractory multiple myeloma who received the treatment at the recommended 2.5 mg/kg dose.2 In patients who received belantamab mafodotin at 3.4 mg/kg, the ORR was 34% (97.5% CI; 23.9-46.0); both ORRs were assessed by an independent review committee (IRC).

The priority review designation follows a November 2017 decision by the FDA to grant belantamab mafodotin a breakthrough therapy designation for the treatment of patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy, including a CD38-directed antibody, and who are refractory to a proteasome inhibitor and an IMiD.

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