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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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EMA recommends a new indication for daratumumab in adult patients with newly diagnosed myeloma who are eligible for autologous stem cell transplant

On 19 September the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for daratumumab (Darzalex®, commercialised by Janssen). The new indication is a combination of daratumumab, bortezomib, lenalidomide and dexamethasone and it brings a significant benefit with respect to progression-free survival compared to…

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