完整说明书详见:https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/aad3ba54-dfd3-4cb3-9e2b-c5ef89559189/spl-doc?hl=Tisagenlecleucel 药品知识 药品问答 司利弗明是什么药物?司利弗明(Kymriah)在中国获批了吗? 司利弗明是什么药物?司利弗明(Kymriah)在中国获批了吗?司利弗明(Kymr...[ 详情 ]...
1 Designated an orphan drug by FDA for this indication.2 Efficacy of tisagenlecleucel for this use was evaluated in an open-label, multicenter, single-arm trial (ELIANA) in patients 3–23 years of age with refractory or relapsed (r/r) B-cell precursor ALL.1 3 Treatment consisted of ...
U.S. Food and Drug Administration (FDA). FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma. Drugs. Silver Spring, MD: FDA; May 27, 2022. U.S. Food and Drug Administration (FDA). FDA approval brings first gene therapy to the United States. FDA News. Silver Spr...
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&...
In April 2020, the FDA granted a Regenerative Medicine Advanced Therapy designation to tisagenlecleucel for the treatment of patients with relapsed/refractory follicular lymphoma based on preliminary data from the multicenter, ongoing ELARA trial (NCT03568461). The single-arm, open-label,...
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...
ELARA is an international, single-arm, multicenter, open-label study of the CD19-directed chimeric antigen receptor (CAR) T-cell therapy in patients with relapsed or refractory follicular lymphoma. Patients with grade 1, 2, or 3A follicular lymphoma who had no evidence of histolo...
(CNTO 328, Sylvant; Janssen Pharmaceutica, Beerse, Belgium) is a human murine chimeric monoclonal antibody against IL-6.89 It is FDA-approved since 2014 for the treatment of multicentric Castleman's Disease.90 It is used off-label for management of CRS and, as tocilizumab, can induce rapid ...
weeks following kymriah infusion. advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. patient counseling information advise the patient to read the fda-approved patient labeling...
Among 106 patients receiving tisagenlecleucel included in the FDA label, 62 (58.5%) patients were reported as having NT, including 43 (40.6%) with grade 1/2 and 19 (17.9%) with grade 3 or higher NT. By comparison, the expert regrading of the 62 patients identified as having NT in ...