FDA Grants Breakthrough Therapy Designation to Izalontamab Brengitecan in EGFR+ NSCLC

Key Takeaways

• Iza-bren targets EGFR and HER3, showing potential in treating EGFR-mutant NSCLC after progression on EGFR TKI and platinum-based chemotherapy.
• The FDA’s breakthrough therapy designation highlights iza-bren’s potential to improve clinical outcomes for previously treated EGFR-mutated NSCLC patients.
• Clinical trials focus on determining the recommended phase 2 dose, safety, and efficacy, including combination therapy with osimertinib.
• Iza-bren’s dual mechanism blocks EGFR and HER3 signals, with a payload causing genotoxic stress, offering a novel approach to NSCLC treatment.

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