Legend Biotech Announces Submission of Supplemental Applicat

Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel)

The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival compared to standard regimens


CARTITUDE-4 is the... | June 6, 2023

Related Keywords

Japan , China , United States , New Jersey , American , Ying Huang , Hemophagocytic Lymphohistiocytosis , European Hematology Association , Janssen Biotech Inc , Community Register Of Orphan Medicinal Products , Exchange Commission On , Twitter , Linkedin , American Cancer Society , European Commission , Medicinal Devices Agency , Data Monitoring Committee , American Society Of Clinical Oncology , Drug Administration , Japan Ministry Of Health , European Commission For The Treatment Of Patients , Legend Biotech Corporation , Legend Biotech , Biologics License Application , Chief Executive Officer , Clinical Oncology , Annual Meeting , New England Journal , Hematology Association , Hybrid Congress , Independent Data Monitoring Committee , Release Syndrome , Effector Cell Associated Neurotoxicity Syndrome , Macrophage Activation Syndrome , Risk Evaluation , Mitigation Strategy , Mediated Myelitis , Nerve Palsies , Recurrent Cytopenias , Igg Hypersensitivity Reactions , Janssen Biotech , Use Machines , Prescribing Information , Boxed Warning , Breakthrough Therapy Designation , Orphan Drug Designation , European Medicines Agency , Orphan Medicinal Products , Private Securities Litigation Reform Act , Annual Report , Exchange Commission , Standard Care , Lenalidomide Refractory Multiple , Adult Patients , Refractory Multiple , Accessed March , Granted Conditional Approval , Receives Approval , Community Register , Orphan Medicinal , Statistics About Multiple Myeloma , Legend Biotech Corporation Stock Exchange , News , Information , Press Release , The , Application , Us , Upported , Y , Hase , , Which , Howed , Significant , Improvement , N , Primary , Ndpoint , F , Survival , Ompared , O , Standard , S Legn Us52490g1022 ,

© 2025 Vimarsana