Posted by Michael Wonder on 23 Jul 2025
DualityBio's next generation HER3 ADC DB-1310 granted FDA fast track designation
21 July 2025 - DualityBio announced that the US FDA has granted fast track designation to its next-generation HER3 targeting antibody drug conjugate DB-1310.
This designation is for the treatment of adult patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.
