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Watch our webinar “How are costs and medicine effectiveness part of decision-making in medicine access?”

Aimed at patients, carers and patient advocates, as well as to a general audience, the webinar provides basic knowledge on the topic of cost-effectiveness analysis in decision-making (including health technology assessment) on new medicines. This webinar was organised as part of the ASCERTAIN project, which works to improve affordability and accessibility to innovative health technologies across…

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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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