EMA CHMP recommends non-renewal of marketing authorisation for Blenrep®

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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 (e.g., bortezomib), one immunomodulatory agent (e.g., lenalidomide), and an anti-CD38 monoclonal antibody (e.g., daratumumab), and whose cancer has worsened since…

EMA recommends expansion of melphalan flufenamide (Pepaxti®) marketing authorisation

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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 have received at least three prior lines of therapy and are refractory to at least one proteasome inhibitor (such as…

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

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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

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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

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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).…

Sign up for the MPE webinar on EHA myeloma and AL amyloidosis highlights 

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Myeloma Patients Europe (MPE) will host a webinar to summarise the most important myeloma and AL amyloidosis updates presented at the congress on 6 July 2023, from 17:00 – 18:00 CET, given by Prof. Dr. Mohamad Mohty, Professor and Head of the Hematology and cellular therapy department at the Saint-Antoine Hospital and Sorbonne University (Paris, France).   If you would like to attend, click here and register now!   The European Hematology Association (EHA) 2023 hybrid congress took place from…

MPE interviews experts about different aspects of the CARAMBA clinical trial

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As part of the Horizon 2020 CARAMBA project, Myeloma Patients Europe (MPE) interviewed experts on different aspects of the CARAMBA clinical trial: manufacturing process, safety updates, and immune monitoring. The videos were filmed during the ASH annual meeting in December 2022. The CARAMBA project is a phase I/II clinical trial investigating innovative immunotherapy for treating myeloma, known as Chimeric Antigen Receptor T-cell therapy (CAR-T). Through strategic collaboration with a wide range of stakeholders, including MPE,…