European Commission approves CAR T-cell therapy ciltacabtagene autoleucel in earlier lines of therapy for relapsed and refractory myeloma

  The European Commission has approved marketing authorisation extension for the CAR-T treatment ciltacabtagene autoleucel (Carvytki®), also known as cilta-cel, for use in patients who have received at least one prior therapy, including an immunomodulatory agent (IMiD – such as lenalidomide and pomalidomide) and a proteasome inhibitor (PI – such as bortezomib or carfilzomib), have demonstrated disease progression on the last therapy and are refractory (i.e. no longer responding) to lenalidomide. This follows an earlier…

MPE gives feedback on the proposed implementing act supporting the EU Health Technology Assessment regulation

  The European Commission recently held an online public consultation on the first draft implementing act supporting the EU health technology assessment (HTA) regulation. The EU HTA regulation will be implemented from 2025 and aims to increase the collaboration on health technology assessment across EU member states. Implementing acts set out the legislative detail of different elements of a regulation. The first of six implementing acts, the draft outlines the process for conducting joint clinical…

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 received at least three previous lines of therapy. The extension means that ide-cel will now be indicated for the treatment…

MPE announces partnership in EU consortium project CERTAINTY: advancing cancer care through virtual twins in personalised immunotherapy

  MPE announces partnership with an international team, including representatives from scientific, industry, and healthcare sectors, as part of the EU-funded research project CERTAINTY, which began in December 2023. The EU consortium “CERTAINTY – A cellular immunotherapy virtual twin for personalized cancer treatment” is being funded by the European Union with almost EUR 10 million over the next 4.5 years within the Horizon Health 2023 program. The project, led by the Fraunhofer Institute for Cell Therapy…

ESMO 2023 | Patient Advocacy Track highlights challenges in access, caregiver support and digitalisation

35.000 people attended the European Society for Medical Oncology (ESMO) Annual Congress, held from 20 to 24 October in Madrid, Spain, where the latest data in oncology research and development was presented. Along with several updates, mostly in solid tumours, different advocacy topics were discussed as part of the Patient Advocacy Track. Myeloma Patients Europe (MPE) was represented by Kate Morgan, MPE Co-Chief Executive Officer, and Lise-lott Eriksson, MPE president who participated in one of…

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 targets the CD3 receptor on T cells and BCMA on plasma cells, including those in malignant multiple myeloma. Elranatamab is…

A statement from MPE on the situation in Israel and Gaza

MPE and our community are extremely saddened by the ongoing and devastating events in Israel and Gaza. The death of hundreds of innocent people is completely unacceptable, and our deepest sympathy goes out to everyone affected. We know our members are continuing to provide support to patients and their families during this difficult time. All myeloma patients and caregivers in Israel who need support or have concerns should contact Varda Shoham from AMEN at: