LONDON (dpa-AFX) - GlaxoSmithKline plc. (GSK, GSK.L) said that the US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee to review data supporting the company's Biologics License Application or BLA for belantamab mafodotin for the potential treatment of patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The Oncologic Drugs Advisory Committee or ODAC will meet virtually on 14 July 2020.
Belantamab mafodotin received Breakthrough Therapy Designation in 2017, and the BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal DREAMM-2 or DRiving Excellence in Approaches to Multiple Myeloma study.
Belantamab mafodotin is a potential first-in-class, humanised, anti-BCMA (antibody drug conjugate against B-cell maturation antigen) being investigated in a robust clinical trial programme for the treatment of multiple myeloma.
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