DATROWAY approved in the U.S. as first TROP2 directed therapy for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

CAR-T Digest - August 2020

Weekly Digest - June 2025

23 June 2025: DATROWAY approved in the U.S. as first TROP2 directed therapy for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

DATROWAY (datopotamab deruxtecan-dlnk) received accelerated approval in the U.S. for treating adult patients with locally advanced/metastatic EGFR-mutated NSCLC who previously received EGFR therapy and platinum chemotherapy
The approval is based on ORR and DoR data from the TROPION-Lung05 and TROPION-Lung01 trials, which showed a confirmed ORR of 45% and a median DoR of 6.5 months
DATROWAY is the first TROP2-directed ADC approved for lung cancer in the U.S., developed by Daiichi Sankyo and AstraZeneca
Safety data from 125 patients showed common adverse events (≥20%) like stomatitis, nausea, alopecia, and fatigue; serious adverse reactions occurred in 26% of patients
Ongoing TROPION-Lung14 and Lung15 phase 3 trials are evaluating DATROWAY alone or in combination with osimertinib in other EGFR-mutated NSCLC settings