Helping patients reclaim a life of possibility
Myeloma Patients Europe (MPE) will hold a webinar on the generics market in Europe and implications for cancer treatment and care on Monday 30th March from 17:00 – 18:30 CET. A generic medicine has the same active ingredient as a branded medicine and can be produced after the patent for the branded medicine expires. For…
The US Food and Drug Administration (FDA) has issued draft guidance to the pharmaceutical industry on using minimal residual disease (MRD) and complete response (CR) in myeloma clinical trials as a primary endpoint, to support approval under accelerated assessment. This follows a previous decision of the US FDA’s Oncology Drugs Advisory Committee (ODAC) to accept…
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…
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 for Medicinal Product for Human Use (CHMP) in June 2025. The CHMP is the European Medicines Agency’s (EMA) committee playing…
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…
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.…
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…
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 CET. The webinar will be given by Tom Belleman, PhD candidate at the Erasmus School of Health Policy and Management…