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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

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