• By ICR Secretariat
  • Posted Tuesday, November 12, 2019

Celgene posts pivotal CAR-T data ahead of FDA filing

https://www.fiercebiotech.com/biotech/celgene-posts-pivotal-car-t-data-ahead-fda-filing

Celgene has posted data from a pivotal trial of its CAR-T therapy. The data look competitive against Gilead’s Yescarta and Novartis’ Kymriah, leading analysts to predict Celgene will win FDA approval next year.
 
Investigators administered lisocabtagene maraleucel (liso-cel), an anti-CD19 CAR-T, to 262 patients with large B-cell lymphomas. Among the 255 patients evaluable for efficacy, the complete response rate was 53%. The overall response rate came in at 73%, and the median duration of response was 13.3 months.