DATROWAY® Approved in the U.S. as First TROP2-Directed Treatment for Advanced EGFR-Mutated Lung Cancer
Tuesday, June 24, 2025
DATROWAY® (datopotamab deruxtecan-dlnk) has received accelerated approval in the United States for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR mutations, following prior treatment with EGFR-targeted therapies and platinum-based chemotherapy.
This marks the first TROP2-directed therapy approved in this setting. The decision was granted under the FDA’s accelerated approval pathway, based on results showing objective response rate (ORR) and duration of response (DoR). Continued approval may depend on confirmation of clinical benefit in further studies.
DATROWAY is a TROP2-directed DXd antibody-drug conjugate (ADC), developed by Daiichi Sankyo and co-developed with AstraZeneca. The approval follows a Priority Review and Breakthrough Therapy Designation supported by data from the TROPION-Lung05 (phase 2) and TROPION-Lung01 (phase 3) clinical trials.
Across these studies, DATROWAY achieved a confirmed ORR of 45% in previously treated patients (n=114), with complete responses seen in 4.4% and partial responses in 40%. The median DoR was reported at 6.5 months.
Safety data from a pooled group of 125 patients across three trials showed common adverse reactions (≥20%) included stomatitis, nausea, fatigue, alopecia, and decreased blood counts. Serious adverse events occurred in 26% of patients, with COVID-19, stomatitis and pneumonia reported in over 1%.
The approval brings a new treatment option to patients with EGFR-mutated NSCLC whose disease has progressed after earlier therapies. DATROWAY is also being studied in combination with osimertinib in ongoing phase 3 trials (TROPION-Lung14 and TROPION-Lung15), exploring its potential in other advanced lung cancer settings.
Support services for healthcare providers and patients in the U.S., including access and reimbursement assistance, are available through DATROWAY4U.
Source: businesswire.com
