Datopotamab Deruxtecan-dlnk Granted Accelerated Approval for EGFR-Mutated NSCLC
Expert Perspectives · Lyn Brook · 2025-06-25
The FDA has granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway®, Daiichi Sankyo, Inc.) for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
Why This Approval Matters
The accelerated approval of datopotamab deruxtecan-dlnk provides a new treatment option for patients with EGFR-mutated NSCLC whose disease has progressed following EGFR-directed therapy and platinum-based chemotherapy. This approval addresses a significant unmet need for patients with limited options after standard therapies.
Breaking Down the TROPION-Lung Trials
Efficacy was evaluated across two clinical trials: TROPION-Lung05 (NCT04484142), a multicenter, single-arm trial, and TROPION-Lung01 (NCT04656652), a multicenter, open-label, randomized controlled trial. A pooled subgroup of 114 patients with locally advanced or metastatic EGFR-mutated NSCLC who had previously received EGFR-directed therapy and platinum-based chemotherapy received datopotamab deruxtecan-dlnk at the recommended dose across both clinical trials.
The primary efficacy end points measured were confirmed overall response rate (ORR) and duration of response (DOR), as determined by blinded independent central review per RECIST v1.1. Datopotamab deruxtecan-dlnk produced an ORR of 45% and a median DOR of 6.5 months.
Managing Adverse Events
The prescribing information for datopotamab deruxtecan-dlnk includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. Clinicians should monitor for these adverse events and manage them according to established guidelines.
Clinical Implications and Future Outlook
“Encouraging and durable antitumor activity was observed with datopotamab deruxtecan-dlnk in this heavily pretreated advanced/metastatic NSCLC population with actionable genomic alterations,” concluded Jacob Sands, MD, a Thoracic Medical Oncologist at Dana-Farber Cancer Institute, and colleagues, in their published results from the TROPION-Lung05 Study. “The rate of treatment-related grade ≥3 toxicities was comparable with previous observations, and no new safety signals were observed.”
Dosing and Administration
The recommended dose of datopotamab deruxtecan-dlnk is 6 mg/kg—up to a maximum of 540 mg for patients ≥90 kg—administered as an intravenous infusion once every three weeks, until disease progression or unacceptable toxicity.