FDA grants FTD to DB-1310 for advanced or metastatic non-squamous NSCLC

CAR-T Digest - August 2020

22 July 2025: FDA grants FTD to DB-1310 for advanced or metastatic non-squamous NSCLC

DB-1310, an ADC targeting HER3, has received Fast Track Designation from the U.S. FDA for advanced or metastatic non-squamous NSCLC patients with EGFR exon 19 deletion or L858R mutation after TKI and platinum-based chemotherapy
The drug is designed for patients who have progressed on third-generation EGFR tyrosine kinase inhibitors and platinum chemotherapy
DB-1310 is developed using the company’s proprietary DITAC platform to target HER3 in solid tumors
First-in-human Phase 1/2a clinical trial data (NCT05785741) was presented at the 2025 ASCO Annual Meeting