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On September 15, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended non-renewal of marketing authorisation for belamaf mafadotin (Blenrep®).   Blenrep is currently approved for myeloma patients who have received at least four previous treatments and have stopped responding to at least one proteasome inhibitor…

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has granted a positive opinion on the application for an extended marketing authorisation (i.e. a license) for melphalan flufenamide (Pepaxti), also called melflufen.   Melflufen, in combination with dexamethasone,  is currently licenced in the EU for treating myeloma patients who…

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,…

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…

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…