Daiichi Sankyo and AstraZeneca Receive Approval for DATROWAY® in Advanced EGFR-Mutated NSCLC
Tuesday, June 24, 2025
Daiichi Sankyo and AstraZeneca have received accelerated approval from the U.S. Food and Drug Administration (FDA) for DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations.
DATROWAY is a TROP2-directed ADC composed of a humanised anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor payload using a cleavable linker. It is part of Daiichi Sankyo’s DXd ADC pipeline and a key component of AstraZeneca’s oncology portfolio.
Non-small cell lung cancer (NSCLC) accounts for nearly 87% of all lung cancer cases globally. Among these, EGFR mutations are present in around 10–15% of U.S. and European patients, and up to 40% of those in Asia.
TROPION-Lung05 is a global, single-arm, phase 2 trial involving patients with actionable genetic alterations in NSCLC who had received prior targeted therapy and platinum-based chemotherapy. The study enrolled 137 patients worldwide and focused on ORR as the primary endpoint.
TROPION-Lung01 is a phase 3 trial comparing DATROWAY with docetaxel in previously treated patients with and without actionable mutations. The primary endpoints are progression-free survival (PFS) and overall survival (OS). It enrolled 590 patients across five continents.
TROPION-PanTumor01 is a phase 1 trial assessing DATROWAY in patients with advanced solid tumours. The study evaluated safety and preliminary efficacy across various tumour types and enrolled 890 patients in Asia and North America.
This approval applies to patients who have previously been treated with EGFR-targeted therapy and platinum-based chemotherapy. The decision is based on objective response rate (ORR) and duration of response (DoR), with continued approval potentially subject to confirmation of clinical benefit in further studies.
The approval is based on data from the TROPION-Lung05 and TROPION-Lung01 trials. In these studies, DATROWAY showed an objective response rate (ORR) of 45% in patients with previously treated EGFR-mutated NSCLC. Among 114 patients assessed by blinded independent central review, complete responses were reported in 4.4% of cases and partial responses in 40%. The median duration of response (DoR) was 6.5 months.
The safety profile was evaluated in a pooled analysis of 125 patients across three trials. The most common side effects (occurring in 20% or more of patients) included stomatitis, nausea, fatigue, alopecia, constipation, and changes in blood parameters. Serious adverse reactions were reported in 26% of patients, with COVID-19, stomatitis, and pneumonia among the most frequent.
Continued approval may depend on further confirmation of clinical benefit.
Source: daiichisankyo.us
