2.FDA approval brings first gene therapy to the United States. FDA. August 30, 2017. Accessed September 4, 2024. 声明 本资讯旨在帮助医疗卫生专业人士更好地了解相关疾病领域最新进展。本公众号对发布的资讯内容,并不代表同意其描述...
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Based on data from the phase II JULIET study, tisagenlecleucel has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma&...
Tisagenlecleucel was the first CAR T-cell therapy to receive FDA approval and this first CAR T-cell product to be approved in 2 distinct indications, according to Novartis. The product was developed in collaboration with the Perelman School of Medicine at the University of Pennsylva...
In August 2017, the FDA took historic action in granting the first approval of gene therapy to tisagenlecleucel. This landmark step brought CAR T-cell therapy to the commercial space and heralded a new era in managing refractory B-cell malignancies and FDA oversight of gene-modified therapies...
The FDA approved tisagenlecleucel based on fi ndings from the phase 2 ELIANA trial (NCT02435849),2 in which investigators reported an 81% CR in 75 children, adolescents, and young adults who received an infusion. In that trial, the 12-month OS and EFS rates were 76% and ...
Another first-in-class to receive FDA approval was Axicabtagene ciloleucel, the first anti-CD19 CAR-T cell product to be approved for the treatment of adult patients with aggressive r/r B-NHL, including r/r DLBCL, transformed follicular lymphoma and primary mediastinal B-cell lymphoma [10...
FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma; https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-axicabtagene-ciloleucel-relapsed-or-refractory-follicular-lymphoma (2021). Chong, E. A. et al. CD...
(CAR-T cell therapy has emerged as a potential therapeutic option for r/r B cell malignancies, which have motivated the FDA approval of a series of products based on this technique. In a systematic review, these investigators examined the safety and effectiveness of CAR-T cell therapy for ...
In recent years, the biopharmaceutical industry has experienced a significant growth in the production and approval of biopharmaceutical products, and typically 20–30 new products gain approval annually by the FDA. For instance, during the five year period between January 2014 and Dec 2019, the tot...