FDA approves elranatamab (ELREXFIO™) for relapsed or refractory myeloma

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On August 14, 2023, the United States Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.).   According to the FDA, elranatamab is indicated for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (such as bortezomib, carfilzomib or ixazomib), an immunomodulatory agent (such as lenalidomide, pomalidomide or thalidomide), and an anti-CD38 monoclonal antibody (such as daratumumab or isatuximab).…

FDA grants talquetamab (TALVEY™) accelerated approval for relapsed or refractory myeloma

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On August 9, 2023, the United States Food and Drug Administration (FDA) granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.). According to the FDA, talquetamab is indicated for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor (such as bortezomib, carfilzomib or ixazomib), an immunomodulatory agent (such as lenalidomide, pomalidomide or thalidomide), and an anti-CD38 monoclonal antibody (such as daratumumab or isatuximab).…

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…