Monthly Archives: August 2023

European Commission approves talquetamab for the treatment of relapsed and refractory myeloma

The European Commission (EC) has granted conditional marketing approval to talquetamab (Talvey®) for the treatment of relapsed and refractory myeloma. These patients must have undergone at least three prior treatments, including an immunomodulatory agent (such as lenalidomide or pomalidomide), a proteasome inhibitor (such as bortezomib or carfilzomib), and an anti-CD38 antibody (such as daratumumab). Additionally, they must have demonstrated disease progression on their most recent therapy.   Talquetamab is a bispecific antibody which targets the…

FDA approves elranatamab (ELREXFIO™) for relapsed or refractory myeloma

On August 14, 2023, the United States Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.).   According to the FDA, elranatamab 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).…

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).…