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

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…

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Job Offer – Access and Policy Manager

Job Title: Access and Policy Manager Position Type: Full time/permanent  Location: Home-based in Belgium, UK, Germany, France or Spain. Other locations in the EU would be considered depending on experience Travel required: 30 days / year (approx.) Gross salary range: 40.000 – 50.000 EUR/year (35.000-45.000 GBP/year)   If you wish to apply or have any questions, please send an email to  with a cover letter and CV.   As Access and Policy Project Manager, you will work…

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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…

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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).…

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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).…

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