Horizon Europe research project looks to improve the affordability and sustainability of innovative health technologies

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  Starting in December 2022, the HORIZON-funded project ASCERTAIN (Affordability and Sustainability improvements through new pricing, Cost- Effectiveness and Reimbursement models to Appraise innovative health technologies) will address the need of patients, physicians, payers, regulators, and manufacturers to improve the affordability and accessibility to innovative health technologies (including pharmaceuticals) in Europe. Affording newly approved innovative health technologies (IHTs) is challenging in many health systems.

Join MPE’s webinar on Access Barriers to Clinical Trials in CEE Countries

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Myeloma Patient Europe (MPE) has been aware of the lack of clinical trials opening in many Central and Eastern European (CEE) countries, as well as inequalities in access with CEE countries for participating in ongoing trials. To gather data on, and further understand the access situation, MPE conducted research on barriers and facilitators to clinical trials, with a specific focus on CEE countries. The research was completed under the guidance of MPE members from across the region through its CEE…

Myeloma diagnosis can take over 5 months and require more than 4 medical consultations with more than 3 different specialists

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Brussels, 27 September 2022 – For some European myeloma patients, their diagnosis can take over 5 months, require more than 4 medical consultations and involve visits to at least 3 different medical specialists. These are some of the findings of pan-European research conducted by Myeloma Patients Europe (MPE) with the aim of exploring patient and doctor (haematologist) experiences of myeloma diagnosis. MPE ran a survey, and several focus groups and interviews, in which more than 600…

The European Medicines Agency (EMA) approves Melflufen (Pepaxti®) for the treatment of refractory myeloma

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  The European Commission has approved marketing authorisation (e.g. a license) for melphalan flufenamide (also called melflufen), a drug marketed in Europe by Oncopeptides with the name of Pepaxti®. This follows the previous positive recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).

EMA recommends conditional marketing authorisation in Europe for teclistamab for relapsed and refractory myeloma

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The European Medicines Agency (EMA) has recommended a conditional marketing authorisation in the European Union (EU) for teclistamab for the treatment of adult patients with relapsed and refractory myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. Teclistamab, alternatively known under the branded name Tecvayli, is a monoclonal antibody that targets two proteins at the same time: a protein called…

European Commission grants conditional approval to CAR-T cell therapy Carvytki (cilta-cel)

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The European Commission has granted conditional approval to CAR-T cell therapy Carvytki (cilta-cel) for the treatment of relapsed and refractory myeloma.   It has been specifically approved for myeloma patients who have received at least three prior treatments, including a proteasome inhibitor (such as bortezomib and carfilzomib), an immunomodulatory agent (such as lenalidomide or pomalidomide) and an anti-CD38 antibody (such as daratumumab or ixatuximab), and have demonstrated disease progression on last treatment. You can find the full…

US FDA approves ciltacabtagene autoleucel (CARVYKTI) for relapsed or refractory myeloma

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The US Food and Drug Administration (FDA) has approved the CAR-T treatment ciltacabtagene autoleucel (also known as cilta-cel and marketed as Carvykti). Manufactured by Janssen, it is specifically approved for the treatment of patients with relapsed or refractory myeloma after four or more prior lines of therapy, including a proteasome inhibitor (like bortezomib), an immunomodulatory agent (like lenalidomide), and an anti-CD38 monoclonal antibody (like daratumumab or isatuximab). You can find the full Janssen press release…

Access to generic lenalidomide (e.g. Revlimid) in Europe

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Sandoz, a manufacturer of generic medicines, announced the launch of generic lenalidomide in 19 European countries. You can see the full press statement here.    Alternatively known under the branded name “Revlimid”, lenalidomide is a drug licensed and commonly used in the treatment of myeloma – in newly diagnosed, maintenance and relapsed settings.   Lenalidomide was first approved by the European Medicines Agency (EMA) in 2008 and has been solely marketed in Europe by Celgene…