The FDA granted priority review to ciltacabtagene autoleucel, a chimeric antigen receptor T-cell therapy, for the treatment of relapsed or refractory multiple myeloma, according to the agent’s manufacturer.
Ciltacabtagene autoleucel (Janssen, Legend Biotech), also known as cilta-cel, is an autologous, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen on the surface of cancer cells.
“Cilta-cel has shown great promise in the treatment of patients with heavily pretreated multiple myeloma, according to study findings reported to date,” Ying Huang, PhD, CEO, and chief financial officer of Legend Biotech, said in the release. “Today’s priority review designation marks another significant milestone for this cell therapy.”
The FDA granted cilta-cel breakthrough therapy designation in December 2019 and has agreed to a rolling review of the biologics license application.
The BLA was based on results of the phase 1b/phase 2 CARTITUDE-1 trial, in which 97 patients (median age, 61 years; 58.8% men) with relapsed or refractory multiple myeloma received citla-cel. Initial results of the trial, presented at last year’s virtual ASH Annual Meeting and Exposition, showed an overall response rate of 96.9% and a stringent complete response rate of 67% at median follow-up of 12.4 months. Median PFS had not yet been reached.
Updated results of the CARTITUDE study will be presented at next week’s virtual ASCO Annual Meeting.
The FDA has set a target action date of Nov. 29.
Madduri D, et al. Abstract 177. Presented at: ASH Annual Meeting and Exposition (virtual meeting); Dec. 5-8, 2020.