FDA

Datroway gains accelerated approval for EGFR-mutated NSCLC

June 27, 2025

FDA granted accelerated approval to Datroway (datopotamab deruxtecan-dlnk) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who’ve received prior EGFR-directed therapy and platinum-based chemotherapy.

Datopotamab deruxtecan is a TROP-2-directed antibody-drug conjugate composed of a humanized anti-TROP-2 IgG1 monoclonal antibody linked via a cleavable tetrapeptide linker to deruxtecan, a topoisomerase I inhibitor.

Efficacy

Efficacy was evaluated in a pooled subgroup of 114 patients with locally advanced or metastatic EGFR-mutated NSCLC who’d received prior treatment with an EGFR-directed therapy and platinum-based chemotherapy and received Datroway at the recommended dose across two clinical trials. TROPION-Lung05 (NCT04484142) was a multicenter, single-arm trial, while TROPION-Lung01 (NCT04656652) was a multicenter, open-label, randomized controlled trial.

Major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR) determined by blinded independent central review. ORR was 45% (95% confidence interval [CI], 35-54) and median DOR was 6.5 months (95% CI, 4.2-8.4).

Safety

The most common (≥20%) adverse reactions, including lab abnormalities, were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased WBC count, increased LDH, musculoskeletal pain, decreased appetite, increased ALT, and rash.

The prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.

Recommended dose

The recommended dosage of Datroway is 6 mg/kg (max. 540 mg for patients ≥90 kg) as an IV infusion q3wks until disease progression or unacceptable toxicity.

Sources:

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer

Datroway (datopotamab deruxtecan-dlnk) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761464s000lbl.pdf Revised June 2025. Accessed June 26, 2025.