Q&A: US Food and Drug Administration (FDA) approves MRD as a basis for accelerated approval in myeloma

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  Last Friday, the US FDA’s Oncology Drugs Advisory Committee (ODAC) (FDA being the US medicines regulator) voted 12 – 0 to approve minimal residual disease (MRD) as an accepted endpoint for accelerated approval of new myeloma drugs. The committee’s primary role is to review benefit-risk data of new cancer drugs. You can see the full meeting and evidence considered here. The decision means that myeloma drugs may now be approved earlier in the US…

MPE gives feedback on the proposed implementing act supporting the EU Health Technology Assessment regulation

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  The European Commission recently held an online public consultation on the first draft implementing act supporting the EU health technology assessment (HTA) regulation. The EU HTA regulation will be implemented from 2025 and aims to increase the collaboration on health technology assessment across EU member states. Implementing acts set out the legislative detail of different elements of a regulation. The first of six implementing acts, the draft outlines the process for conducting joint clinical…

EMA CHMP gives positive recommendation on CAR T-cell therapy ciltacabtagene autoleucel in earlier lines of therapy for relapsed and refractory myeloma

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  The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA – the EU medicines regulator) has today given a positive recommendation for the extension of the marketing authorisation for the CAR-T treatment ciltacabtagene autoleucel (Carvytki®), also known as cilta-cel, for use in patients who have received at least 1 prior therapy. The full wording of the license extension is as follows:   Carvykti is indicated for the treatment of…

AMEN provides medical information for Arabic speakers in Israel and beyond

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  The population of Israel today is 9.8 million people. Among them, 20% are Arabs (about 2 million people) whose first language is Arabic. Due to this, the Israel Multiple Myeloma Association, AMEN, decided to promote multiple activities that will support Arabic-speaking patients with information about myeloma.   The activities included: A website in Arabic, similar to the one that is running in Hebrew. Translation of an online system that searches the relevant rights of…

GSK announces results from interim analysis of the DREAMM-7 phase III trial

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  On 6 February 2024, GlaxoSmithKline (GSK) announced results from an interim analysis of the DREAMM-7 phase III trial presented at an American Society of Clinical Oncology (ASCO) online plenary session. The trial is evaluating belantamab mafodotin (“belamaf” or trade name Blenrep®) combined with bortezomib plus dexamethasone (BorDex) versus daratumumab plus BorDex in second line and later treatment of relapsed or refractory myeloma.   Key results from the presentation include: A main research question in…

MPE announces partnership in EU consortium project CERTAINTY: advancing cancer care through virtual twins in personalised immunotherapy

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  MPE announces partnership with an international team, including representatives from scientific, industry, and healthcare sectors, as part of the EU-funded research project CERTAINTY, which began in December 2023. The EU consortium “CERTAINTY – A cellular immunotherapy virtual twin for personalized cancer treatment” is being funded by the European Union with almost EUR 10 million over the next 4.5 years within the Horizon Health 2023 program. The project, led by the Fraunhofer Institute for Cell Therapy…

Sign up for the MPE webinar on ASH 2023 myeloma and AL amyloidosis highlights

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Myeloma Patients Europe (MPE) will host a webinar to summarise the most important myeloma and AL amyloidosis updates presented at the 65th American Society of Hematology (ASH) Annual Meeting which will be held 9-12 December, 2023 in San Diego, California, United States.   The webinar will take place on Wednesday, 17 January from 17:00 to 18:00 CET and will be given by Dr. Faith Davies, Director of Clinical Myeloma Programme at NYU Langone Health Perlmutter…

2023: Year in Review

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On behalf of the Myeloma Patients Europe (MPE) Board of Directors and staff, we extend a heartfelt thank you to our members, sponsors and stakeholders for your dedication and inspiration.   This year, MPE achieved significant milestones made possible by our collective efforts, and we are thrilled to present our Year in Review 2023. We hope you’ll take a moment to read this report, which highlights our key accomplishments focused on empowering, educating and supporting the patient…

ESMO 2023 | Patient Advocacy Track highlights challenges in access, caregiver support and digitalisation

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35.000 people attended the European Society for Medical Oncology (ESMO) Annual Congress, held from 20 to 24 October in Madrid, Spain, where the latest data in oncology research and development was presented. Along with several updates, mostly in solid tumours, different advocacy topics were discussed as part of the Patient Advocacy Track. Myeloma Patients Europe (MPE) was represented by Kate Morgan, MPE Co-Chief Executive Officer, and Lise-lott Eriksson, MPE president who participated in one of…