CPO301 granted the third fast track designation by US FDA for the treatment of adult patients with NSCLC

CAR-T Digest - August 2020

19 May 2025: CPO301 granted the third fast track designation by US FDA for the treatment of adult patients with NSCLC

CPO301 (SYS6010 in China) has received its third fast track designation from the FDA for treating advanced or metastatic non-squamous NSCLC without EGFR mutations after progression on chemotherapy and immunotherapy
The fast track status was granted based on encouraging clinical data showing better activity compared to existing therapies in NSCLC and other tumors
It previously earned two fast track designations for treating metastatic NSCLC with EGFR mutations (relapsed or refractory) and recurrent/metastatic squamous NSCLC with EGFR overexpression
CPO301 targets various NSCLC subtypes, including those with EGFR mutations and those overexpressing wild-type EGFR, addressing a broad patient population
CPO301, a humanized antibody linked to a topoisomerase I inhibitor, is in clinical trials in China and the U.S., with FDA designation helping expedite its global progress