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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,…

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…

Myeloma Patients Europe (MPE) has today launched a first-of-its-kind advocacy report on Addressing access barriers to myeloma clinical trials in Central and Eastern Europe (CEE). The report, led by the MPE CEE Workgroup on Access, found huge inequalities for patients, confirming reports from MPE CEE members about a lack of clinical trials opening in the region and…

  The European Commission has approved marketing authorisation (e.g. a license) for melphalan flufenamide (also called melflufen), a drug marketed in Europe by Oncopeptides with the name of Pepaxti®. This follows the previous positive recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency (EMA) has recommended a conditional marketing authorisation in the European Union (EU) for teclistamab for the treatment of adult patients with relapsed and refractory myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. Teclistamab, alternatively known…

Sandoz, a manufacturer of generic medicines, announced the launch of generic lenalidomide in 19 European countries. You can see the full press statement here.    Alternatively known under the branded name “Revlimid”, lenalidomide is a drug licensed and commonly used in the treatment of myeloma – in newly diagnosed, maintenance and relapsed settings.   Lenalidomide…