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

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  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…

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

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  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 extension means that ide-cel will now be indicated for the treatment of patients with relapsed and refractory myeloma who…

EMA CHMP gives positive recommendation on CAR T-cell therapy ciltacabtagene autoleucel in earlier lines of therapy for relapsed and refractory myeloma

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  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 therapy. The full wording of the license extension is as follows:   Carvykti is indicated for the treatment of…

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

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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

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  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…

ASH 2023 | Myeloma and AL amyloidosis updates

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Myeloma Patients Europe (MPE) attended the 65th American Society of Hematology (ASH) Annual Meeting, the largest haematology congress, held from 9 to 12 December in San Diego (United States). MPE has interviewed haematology experts to summarise the latest myeloma and AL amyloidosis updates.     Prof. Dr. Michel Delforge, Department of Haematology, University Hospital Leuven, Belgium, explains the latest findings on the KarMMa-3 trial and the impact abecma has on Quality of Life (QoL) presented at…

Sign up for the MPE webinar on ASH 2023 myeloma and AL amyloidosis highlights

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Myeloma Patients Europe (MPE) will host a webinar to summarise the most important myeloma and AL amyloidosis updates presented at the 65th American Society of Hematology (ASH) Annual Meeting which will be held 9-12 December, 2023 in San Diego, California, United States.   The webinar will take place on Wednesday, 17 January from 17:00 to 18:00 CET and will be given by Dr. Faith Davies, Director of Clinical Myeloma Programme at NYU Langone Health Perlmutter…

Horizon2020 CARAMBA CAR-T interview series

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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 developed myeloma CAR-T products currently under clinical investigation.       Interview of Janssen Pharmaceuticals on their CAR T-cell manufacturing process…

MPE interviews experts about different aspects of the CARAMBA clinical trial

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As part of the Horizon 2020 CARAMBA project, Myeloma Patients Europe (MPE) interviewed experts on different aspects of the CARAMBA clinical trial: manufacturing process, safety updates, and immune monitoring. The videos were filmed during the ASH annual meeting in December 2022. The CARAMBA project is a phase I/II clinical trial investigating innovative immunotherapy for treating myeloma, known as Chimeric Antigen Receptor T-cell therapy (CAR-T). Through strategic collaboration with a wide range of stakeholders, including MPE,…