European Commission approves CAR T-cell therapy ciltacabtagene autoleucel in earlier lines of therapy for relapsed and refractory myeloma

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  The European Commission has approved marketing authorisation extension for the CAR-T treatment ciltacabtagene autoleucel (Carvytki®), also known as cilta-cel, for use in patients who have received at least one prior therapy, including an immunomodulatory agent (IMiD – such as lenalidomide and pomalidomide) and a proteasome inhibitor (PI – such as bortezomib or carfilzomib), have demonstrated disease progression on the last therapy and are refractory (i.e. no longer responding) to lenalidomide. This follows an earlier…

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…

Snežana Doder, young myeloma patient: “When I talk about my journey, I compare it to a roller coaster. Everything happened very fast and unexpectedly”

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  My name is Snežana Doder and I´m from Serbia. When I talk about my journey, I compare it to a roller coaster. Everything happened very fast and unexpectedly. I had a very healthy lifestyle before and underwent regular medical checkups. I am certain that this is why I discovered everything just in time, or even earlier. I was diagnosed completely by accident. I had not experienced any symptoms. Still, I found out that I…

European Commission grants final approval for CAR-T treatment idecabtagene vicleucel (Abecma) in earlier lines of therapy for relapsed and refractory myeloma

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  The European Commission has granted the final approval for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by Bristol-Myers Squibb (BMS) as Abecma®. Ide-cel has previously been approved for the treatment of patients with relapsed and refractory myeloma, who have received at least three previous lines of therapy. The extension means that ide-cel will now be indicated for the treatment of patients with relapsed and refractory myeloma who…

Ana Rocha, young myeloma patient: “I didn’t let the diagnosis change me and I thought I should build something to help others newly diagnosed”

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  My name is Ana Rocha, I´m 53 years old and I’m from Portugal. I was diagnosed with myeloma in July 2021, classified as DSIII A, R-ISS 1, in an emergency hospital after several consultations over eight months.   After the diagnosis, it took almost a month to start the treatments. The first one was on my birthday, and I felt that the universe was giving me a unique opportunity. I did six cycles on…

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…

US FDA approves bi-weekly teclistamab dosing in relapsed/refractory myeloma

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  The US Food and Drug Administration (FDA – the medicines regulator in the US) has granted approval to a “supplemental biologics license application” for teclistamab-cqvy (Tecvayli®). This means the existing FDA teclistamab license has been extended to include administration at a reduced dosing frequency of 1.5 mg/kg every two weeks, instead of once weekly (as is currently the case) for patients with relapsed/refractory myeloma who have maintained a sustained complete response (CR – a…

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…