FDA grants talquetamab (TALVEY™) accelerated approval for relapsed or refractory myeloma
On August 9, 2023, the United States Food and Drug Administration (FDA) granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.). According to the FDA, talquetamab is indicated for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (such as bortezomib, carfilzomib or ixazomib), an immunomodulatory agent (such as lenalidomide, pomalidomide or thalidomide), and an anti-CD38 monoclonal antibody (such as daratumumab or isatuximab).…