The U.S. Food and Drug Administration (FDA) has granted accelerated approval to a new cancer therapy, datopotamab deruxtecan-dlnk (Datroway), for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has an EGFR mutation. This approval is specifically for patients who have already received both EGFR-targeted therapy and platinum-based chemotherapy. Accelerated approval means continued availability depends on confirmatory trials.
Key Facts for Patients:
- Who is eligible?
Adults with advanced or metastatic EGFR-mutated NSCLC who have previously been treated with EGFR-directed therapy and platinum-based chemotherapy. - How effective is it?
In clinical trials, about 45% of patients responded to the treatment. For those who responded, the median duration of response was 6.5 months. - How is it given?
Datroway is administered as an intravenous infusion every three weeks. The recommended dose is 6 mg per kilogram of body weight (up to 540 mg for patients weighing 90 kg or more), and treatment continues until the disease progresses or side effects become unacceptable. - What are the possible side effects?
The prescribing information includes warnings for interstitial lung disease/pneumonitis (lung inflammation), eye problems, mouth sores, and risks to unborn babies. Patients should discuss these risks with their healthcare provider.
This approval is based on results from two clinical trials (TROPION-Lung05 and TROPION-Lung01), which showed promising response rates for patients with this specific type of lung cancer.
- TROPION-Lung05: This Phase 2 trial showed antitumor activity and a manageable safety profile in previously treated advanced/metastatic NSCLC patients with actionable genomic alterations. The confirmed objective response rate (ORR) was 35.8% in the overall population and 43.6% in the subgroup with EGFR mutations.
- TROPION-Lung01: This Phase 3 trial demonstrated improvement in progression-free survival (PFS) in the overall trial population compared to docetaxel. In the nonsquamous NSCLC subgroup, datopotamab deruxtecan also showed an improvement in overall survival (OS) compared to docetaxel.
- Pooled analysis: A pooled analysis of both trials indicated that datopotamab deruxtecan demonstrated tumor response in patients with previously treated advanced or metastatic EGFR-mutated NSCLC.
Datopotamab deruxtecan is a precision cancer medicine known as an antibody drug conjugate (ADC). The anti-TROP2 (trophoblast cell-surface antigen 2) monoclonal antibody delivers a topoisomerase I inhibitor cytotoxic chemotherapy (“payload”) directly to cancer cells via a linker attached to the monoclonal antibody that binds to TROP2 on the cancer cells. TROP2 is a transmembrane glycoprotein that is over expressed in many cancers and is associated with poor overall and disease-free survival. TROP2 expression has been observed in up to 64% and 75% of adeno and squamous cell NSCLC’s respectively.Earlier in 2025, Datroway was FDA approved for patients with hormone receptor-positive (HR+), HER2-negative breast cancer that has spread or cannot be surgically removed.
More Reading
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References
Ahn M-J, et al. Datopotamab deruxtecan (Dato-DXd) vs doxetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): results of the randomized phase 3 study TROPION-Lung01. Presented at: ESMO Congress 2023, 20-24 October 2023; Madrid, Spain. LBA12.
Sands J, et al. Datopotamab Deruxtecan in Advanced or Metastatic Non–Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. JCO 0, JCO-24-01349. DOI:10.1200/JCO-24-01349
