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EMA CHMP gives positive opinion on daratumumab use in smouldering myeloma patients with high risk of developing myeloma

On the 19th June 2025, the Committee for Medicinal Products for Human Use (CHMP) recommended  marketing authorisation for daratumumab for patients with high-risk smouldering myeloma. Daratumumab is a monoclonal antibody marketed by Johnson & Johnson as Darzalex®. This medicine has been designed to recognise and bind to the CD38 protein, which is found on the surface…

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EMA CHMP gives positive opinion on belantamab mafodotin combinations for relapsed/refractory myeloma patients

On the 23 May 2025, the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of two belantamab mafodotin combinations for the treatment of patients with relapsed and/or refractory myeloma. The first combination is with bortezomib (a proteasome inhibitor) plus the steroid dexamethasone (BVd) in patients who have received at least one prior therapy.…

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European Commission approves linvoseltamab for the treatment of relapsed and refractory myeloma

On 23th April 2025, the European Commission has granted conditional marketing approval of linvoseltamab to treat adults with relapsed and refractory myeloma. Conditional approval means that linvoseltamab will be reassessed for safety and efficacy when the results of other, larger clinical trials become available. This approval is based on the favourable recommendation issued by the…

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EMA CHMP gives positive opinion on linvoseltamab for relapsed/refractory myeloma patients

On 27th February 2025, the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of linvoseltamab for the treatment of patients with relapsed/refractory multiple myeloma. The CHMP is the European Medicines Agency’s committee responsible for opinions on all issues regarding medicinal products for human use. Based on these opinions, then the European Commission…

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The European Commission approves isatuximab + VRd combination therapy for newly diagnosed, transplant ineligible myeloma patients

On 22 January 2025, the European Commission approved an isatuximab combination for the treatment of newly diagnosed myeloma patients who are not eligible for a stem cell transplant in the EU. This follows a positive recommendation from the Committee for Medicinal Product for Human Use (CHMP) in November 2024. The CHMP is the European Medicines Agency’s…

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Myeloma and AL amyloidosis ASH 2024 preview

The American Society of Hematology (ASH) Annual Meeting, the world’s largest haematology conference, will take place from 7 – 10 December in San Diego, United States. It is a very exciting event for the myeloma and AL amyloidosis clinical and patient community, with all the results from the latest and most important research being presented.…

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