Helping patients reclaim a life of possibility
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…
Myeloma Patients Europe (MPE) held a webinar to summarise the most important myeloma and AL amyloidosis updates presented at the European Hematology Association (EHA) hybrid 2023 congress. This congress was held in Frankfurt, Germany, in June 2023. The webinar took place on 6th July 2023 and was given by Prof. Dr. Mohamad Mohty, Professor and…
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…
From T-cell collection to CAR T-cell infusion Myeloma Patients Europe (MPE) has conducted four written interviews on CAR-T manufacturing to better understand various myeloma CAR-T therapies’ manufacturing processes and challenges. Four stakeholders have answered our questions, including two pharmaceutical companies, each with a myeloma CAR-T product approved in the European Union, and two academic teams which have…