SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC
Shots:
- The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CT
- Designation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101 trial led by SystImmune, with iza-bren showing improved efficacy across all studies
- Iza-bren is a bispecific ADC targeting EGFR & HER3 with a topoisomerase 1 inhibitor payload, developed by Biokin in China & co-developed by SystImmune & BMS under an exclusive license agreement in territories outside of China
Ref: PR Newswire | Image: BMS & SystImmune | Press Release
Related News:- BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com