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The National Institute for Health and Care Excellence (NICE) approves the use of elranatamab as a fourth-line treatment for myeloma in England and Wales

  On the 21st of June NICE, the United Kingdom’s public body for medicine appraisals, approved the use of the UK’s first bispecific drug for myeloma, elranatamab. Evidence from an ongoing clinical trial showed that the drug can increase the length of time people are in remission. Based on this evidence, elranatamab, commercially known as…

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MPE comments on the second implementing act of the EU health technology assessment (HTA) regulation (EU HTAR)

The EU Health Technology Assessment (HTA) Regulation (EU HTAR) entered into force in January 2022 and will be applied starting in January 2025. It aims to improve the availability of medicines and certain medical devices by establishing EU level joint clinical assessments and joint scientific consultations. It also sets rules for the involvement of patients, clinical experts…

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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…

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MPE launches the Myeloma and AL Amyloidosis European Clinical Trial Navigator

Brussels, 23 April 2024 – Myeloma Patients Europe (MPE) has launched today the English version of the Myeloma and AL Amyloidosis European Clinical Trial Navigator, an online search tool to learn about and find clinical trials for myeloma, monoclonal gammopathy of undetermined significance (MGUS), smouldering multiple myeloma (SMM) and AL amyloidosis in Europe. With this tool, MPE wants to facilitate the search…

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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…

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European Commission grants final approval for CAR-T treatment idecabtagene vicleucel (Abecma) in earlier lines of therapy for relapsed and refractory myeloma

The European Commission has granted the final approval for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by Bristol-Myers Squibb (BMS) as Abecma®. Ide-cel has previously been approved for the treatment of patients with relapsed and refractory myeloma, who have received at least three previous lines of therapy. The…

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EMA CHMP gives positive recommendation on CAR T-cell therapy ciltacabtagene autoleucel 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 – the EU medicines regulator) has today given a positive recommendation for the extension of the marketing authorisation for the CAR-T treatment ciltacabtagene autoleucel (Carvytki®), also known as cilta-cel, for use in patients who have received at least 1 prior…

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