Datopotamab Deruxtecan Receives Accelerated FDA Approval for Previously Treated EGFR-Mutated NSCLC
- Sara Fagerlie, PhD, CHCP
- Jun 23
- 1 min read
On June 23, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who have progressed after prior EGFR-directed therapy and platinum-based chemotherapy.
The approval was based on pooled efficacy data from 114 patients in the TROPION-Lung05 and TROPION-Lung01 studies. TROPION-Lung05 was a phase 2, single-arm trial; TROPION-Lung01 was a phase 3 randomized study that included a relevant subgroup of patients with EGFR-mutated, previously treated NSCLC. In the pooled population, the overall response rate (ORR) was 45% (95% CI, 35–54%), with a median duration of response (DOR) of 6.5 months (95% CI, 4.2–8.4), as assessed by blinded independent central review using RECIST v1.1.
Common adverse reactions to datopotamab deruxtecan included nausea, stomatitis, vomiting, fatigue, decreased appetite, constipation, alopecia, and dry eye. Serious treatment-related toxicities included interstitial lung disease/pneumonitis and ocular disorders.
