The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Immune effector cell-associated neurotoxicity syndrome occurred in 34.9% of patients (grade 3, 20.6%) Most patients (85.7%) experienced cytokine release syndrome (grade 3, 19%). The majority of adults in the study achieved 6-month OS (89.6%) and 12-month OS (62.3%).
Results showed an overall response rate of 93.8% among adults in the study, and 90.6% of adults achieved a minimal residual disease-negative response. “The orphan drug designation from the FDA and the breakthrough designation status granted by the China Center of Drug Evaluation in December 2020 represent significant milestones that demonstrate our belief that CNCT19’s commercialization will not only be successful in China, but potentially on a global scale.”Ī phase 2 study is underway in China to evaluate CNCT19 for adults with relapsed or refractory ALL.Īt this year’s ASH Annual Meeting and Exposition, researchers presented data from 63 patients who received a single infusion of CNCT19 during the phase 1 portion of the study and had a minimum of at least 12 months of follow-up. “Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy,” Wei-Wu He, PhD, chairman and CEO of CASI, said in a company-issued press release. If the FDA approves CNCT19, it would be the first CAR T-cell therapy developed in China available for commercial use in the U.S.
Juventas will develop the therapy and conduct related clinical trials. 11-14, 2021 Atlanta.Ĭhina-based CASI has partnered with Juventas Cell Therapy on a worldwide co-commercialization agreement for CNCT19. Presented at: ASH Annual Meeting and Exposition Dec. The FDA granted orphan drug designation to CNCT19, a chimeric antigen receptor T-cell therapy for the treatment of relapsed or refractory acute lymphoblastic leukemia.ĬNCT19 (CASI Pharmaceuticals and Juventas Cell Therapy) is an autologous, gene-edited CAR T-cell therapy that targets the CD19 protein on the surface of cancer cells.ĭata derived from Liu W, et al. If you continue to have this issue please contact to Healio
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