{"id":25383,"date":"2022-09-28T16:21:00","date_gmt":"2022-09-28T08:21:00","guid":{"rendered":"https:\/\/flcube.com\/?p=25383"},"modified":"2025-02-04T16:30:30","modified_gmt":"2025-02-04T08:30:30","slug":"legend-biotechs-carvykti-approved-in-japan-for-relapsed-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=25383","title":{"rendered":"Legend Biotech’s Carvykti Approved in Japan for Relapsed Multiple Myeloma"},"content":{"rendered":"\n

China-based Legend Biotech Corporation (NASDAQ: LEGN<\/a>) has announced that Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma. The approval is limited to patients who have not previously received CAR-T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, with disease relapse or non-response to the most recent therapy.<\/p>\n\n\n\n

Carvykti: Mechanism and Development<\/strong>
Carvykti is a BCMA-directed, genetically modified autologous T-cell immunotherapy that reprograms a patient\u2019s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) targeting BCMA. BCMA is primarily expressed on malignant multiple myeloma B-lineage cells, late-stage B-cells, and plasma cells. The Carvykti CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.<\/p>\n\n\n\n

Global Approvals and Partnerships<\/strong>
Carvykti was approved by the US Food and Drug Administration in February 2022 and granted conditional marketing authorization by the European Commission in May 2022. The drug is being co-developed globally by Legend Biotech in partnership with Janssen under a December 2017 deal.<\/p>\n\n\n\n

Clinical Trial Results<\/strong>
The approval is based on data from the pivotal Phase Ib\/II CARTITUDE-1 study, which included patients who received a median of six prior treatment regimens. In the study, a one-time treatment with ciltacabtagene autoleucel resulted in durable responses, with 96.9% (95% CI, 91.2-99.4) of patients with relapsed or refractory multiple myeloma (RRMM) in the non-Japanese population responding to therapy (n=97). A total of 67% (95% CI, 56.7-76.2) achieved a stringent complete response (sCR), with no signs or symptoms of disease observed post-treatment. The efficacy results in Japanese patients were consistent with the non-Japanese population. At a median of 18 months follow-up, the median duration of response (DOR) was 21.8 months in non-Japanese patients.<\/p>\n\n\n\n

Safety Profile<\/strong>
The safety of cilta-cel was evaluated in 106 adult patients in the CARTITUDE-1 study, including 97 non-Japanese and 9 Japanese participants. Adverse reactions were observed in 105 (99.1%) of 106 patients treated with cilta-cel. The most common adverse reactions included cytokine release syndrome (94.3%), cytopenia (79.2%), neutropenia (75.5%), thrombocytopenia (59.4%), anemia (51.9%), neurologic events (39.6%), infections (19.8%), and hypogammaglobulinemia (11.3%).-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan\u2019s Ministry of Health, Labour and…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[21,77,112,873,15],"class_list":["post-25383","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-car-t","tag-cell-therapy","tag-legend-biotech","tag-nasdaq-legn","tag-product-approvals"],"yoast_head":"\nLegend Biotech's Carvykti Approved in Japan for Relapsed Multiple Myeloma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) has approved Carvykti (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma. 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