Food and Drug Administration in February 2022 and received conditional marketing approval from the European Medicines Agency in May 2022. 21, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will present six poster presentations featuring data 2 days ago · SOMERSET, N. Jul 17, 2025 · Oncologic Drugs Advisory Committee Meeting FDA Introductory Comments July 17, 2025 BLA Clinical Review and Evaluation sBLA 125746/74, CARVYKTI (ciltacabtagene autoleucel) Clinical Reviewer: Helkha Peredo-Pinto MD, MPH Table of Tables (Applicant) Table 1 Table 2: Table 3: 2 days ago · The treatment of multiple myeloma has changed significantly in the last decade. CARVYKTI (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent CARVYKTI® (ciltacabtagene autoleucel) is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. Ciltacabtagene autoleucel is used to treat multiple myeloma (a type of cancer of the bone marrow) in certain patients. ^ "FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy" (Press release). It is used when at least one other treatment has not worked or has stopped working. 21, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will present six poster presentations featuring data 2 days ago · Legend Biotech (NASDAQ: LEGN) will present six posters on CARVYKTI® (ciltacabtagene autoleucel) at the Tandem Meetings, Feb 4-7, 2026, summarizing clinical and real-world evidence across CARTITUDE trials. Ciltacabtagene autoleucel, also known as cilta-cel (Carvykti) Obecabtagene autoleucel, also known as obe-cel (Aucatzyl) Many other CAR T-cell therapies (and similar types of treatment) are now being studied in clinical trials, in the hope of treating other types of cancer as well. Long-term (‡5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM). pdf Size: 32. Explore how Johnson & Johnson Innovative Medicine applies rigorous science and patient-centered innovation to transform healthcare—with breakthrough treatments in oncology, immunology, neuroscience and beyond. Abstract: Multiple myeloma is a heterogeneous condition characterized by the proliferation of monoclonal B-cells, for which there is currently no curative treatment available. However, regulatory focus on … 3 days ago · Name: Op05 efficiency frontier analysis of ciltacabtagene autoleucel for relapsed refractory multiple myeloma in brazil. This will ensure a comprehensive database of adverse events including malignancies, if any in the local population, thereby ensuring patient safety in the country. ) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy product made up of a patient’s own T cells that are harvested and genetically modified. Jul 19, 2025 · Chimeric antigen receptor (CAR) T-cell therapy has shown impressive efficacy in treating relapsed or refractory multiple myeloma. , lenalidomide, thalidomide, pomalidomide), and are refractory to Ciltacabtagene autoleucel (cilta-cel) was approved by the Food and Drug Administration in February 2022 for the treatment of relapsed/refractory multiple myeloma after four lines of therapy. Antibody-drug conjugates, T-cell immunotherapies including bispecific T-cell engaging antibodies and chimeric antigen receptor T-cell therapies, have shown remarkable results in pivotal clinical trials. . On the CARTITUDE-1 trial, grade ≥3 cytopenias and Jan 15, 2026 · Among 198 patients treated with ciltacabtagene autoleucel or idecabtagene vicleucel (June 2021–December 2024), 27 (13. The risk/benefit profile of cilta-cel remained favorable with longer follow-up. Apr 7, 2024 · This press release covers the FDA-approval of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This has resulted in European Medicines Agency and US Food and Drug Administration approval of agents targeting Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the CAT plenary session to be held 21-23 January 2026.

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