FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for NSCLC
The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Datroway (Datopotamab deruxtecan) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
These patients received previous treatments with EGFR-directed therapy as well as platinum-based chemotherapy.
The indication has gained approval under an accelerated pathway based on the duration of response (DoR) and objective response rate (ORR).
Continued approval may depend on further confirmation and detailed clinical benefit from a confirmatory study.
Datroway is a targeted trophoblast cell surface antigen 2 (TROP2)-directed DXd antibody drug conjugate (ADC), developed using Daiichi Sankyo’s DXd ADC Technology.
It is being co-developed and commercialised by both AstraZeneca and Daiichi Sankyo.
AstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson stated: “This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation.
“We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community.”
The FDA approval follows priority review and breakthrough therapy status and is further supported by subgroup analysis results from the TROPION-Lung05 Phase II trial and outcomes from the TROPION-Lung01 Phase III study.
It is undergoing evaluation in combination with Tagrisso (osimertinib) in Phase III trials named TROPION-Lung14 and TROPION-Lung15, targeting various stages of advanced or metastatic EGFR-mutated NSCLC.
In May 2025, Daiichi Sankyo and MSD withdrew their biologics licence application (BLA) in the US for patritumab deruxtecan, a HER3-directed DXd ADC to treat NSCLC. The decision was based on the results from the Phase III HERTHENA-Lung02 trial, which failed to achieve statistical significance in overall survival.
“FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for NSCLC” was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
