Data from FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Autor: Richard Pazdur, Marc R. Theoret, Wilson Bryan, Bindu George, Ke Liu, Shiowjen Lee, Denise Gavin, Donna Przepiorka, Iftekhar Mahmood, Xue Lin, Ying Huang, Xiaobin Lu, Maura C. O'Leary
Rok vydání: 2023
DOI: 10.1158/1078-0432.c.6526745
Popis: Tisagenlecleucel (Kymriah; Novartis Pharmaceuticals) is a CD19-directed genetically modified autologous T-cell immunotherapy. On August 30, 2017, the FDA approved tisagenlecleucel for treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory in second or later relapse. Approval was based on the complete remission (CR) rate, durability of CR, and minimal residual disease (MRD) See related commentary by Geyer, p. 1133
Databáze: OpenAIRE