Bristol Myers Squibb and SystImmune announced that the US FDA has granted breakthrough therapy designation to their investigational drug, Iza-bren, for advanced EGFR-mutant lung cancer in patients who have progressed after prior treatments.
Iza-bren is a potential first-in-class bispecific antibody-drug conjugate targeting EGFR and HER3, carrying a topoisomerase I inhibitor payload. Originally developed by Biokin in China, the therapy is co-developed globally by SystImmune and Bristol Myers Squibb under an exclusive license agreement.
The FDA’s breakthrough designation is designed to accelerate the development and review of therapies that may provide substantial improvement over current standards of care.