News - Myeloma Patients Europe

US Food and Drug Administration (FDA) issues draft guidance on minimal residual disease

28 January 2026

The US Food and Drug Administration (FDA) has issued draft guidance to the pharmaceutical industry on using minimal residual disease (MRD) and complete response (CR) in myeloma clinical trials as a primary endpoint, to support…

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

15 October 2025

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…

European Commission approves first treatment for high-risk smouldering myeloma

24 July 2025

The European Commission (EC) has approved a new indication for daratumumab (Darzalex®) for the treatment of adult patients with smouldering myeloma (SMM) at high-risk of developing myeloma. This follows a positive recommendation from the Committee…

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

27 June 2025

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…

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

28 May 2025

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…

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

29 April 2025

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…

Register now to join the webinar ‘How do different countries make decisions on reimbursing new medicines?’

6 March 2025

The Horizon Europe funded project ASCERTAIN invites you to the webinar “How do different countries make decisions on reimbursing new medicines?” The webinar will take place on Wednesday 2nd April 2025, from 16:00 to 17:30…

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

3 March 2025

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…

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