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EMA CHMP gives positive opinion on CAR-T treatment idecabtagene vicleucel (Abecma) in earlier lines of therapy for relapsed and refractory myeloma

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has given a positive recommendation for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by BMS as Abecma®. Ide-cel is currently approved for the treatment of patients with relapsed and refractory myeloma, who have…

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EMA CHMP confirms recommendation for non-renewal of Blenrep marketing authorisation

The European Medicines Agency (the EU medicines regulator) Committee for Medicinal Products for Human Use (CHMP) has today confirmed their earlier recommendation to not renew marketing authorisation for belamaf mafadotin (Blenrep®). The confirmation follows a review of the CHMP decision, requested by the manufacturer GSK. MPE Co-Chief Executive Officer, Kate Morgan, commented: “The final recommendation…

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The European Commission grants final approval for elranatamab for the treatment of relapsed or refractory myeloma

The European Commission has granted conditional marketing authorisation for elranatamab, also known as Elrexfio® marketed by the pharmaceutical company Pfizer. This follows an earlier positive recommendation from the European Medicines Agency (EMA – the EU drug licensing body) Committee for Medicinal Products for Human Use (CHMP), after which the European Commission had 60 days to…

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EMA CHMP gives positive recommendation to elranatamab for the treatment of relapsed or refractory myeloma

On October 12, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) gave positive recommendation for the conditional marketing authorisation of elranatamab, also known as Elrexfio. The treatment will be offered as a 40 mg/ml solution for injection. Its active component, elranatamab, is a bispecific monoclonal antibody that…

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