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

  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…

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

  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

  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”

  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

  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

  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…

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

  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…

EMA CHMP gives positive opinion on CAR-T treatment idecabtagene vicleucel (Abecma) in earlier lines of therapy for relapsed and refractory myeloma

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has given a positive recommendation for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by BMS as Abecma®. Ide-cel is currently 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…

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

  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…