TROP2-directed Antibody-drug Conjugate Approved for EGFR-mutated Lung Cancer
The FDA has approved datopotamab deruxtecan-dlnk for certain patients with non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbors EGFR mutations and has previously been treated with EGFR-directed therapy and chemotherapy.
Datopotamab deruxtecan-dlnk is an antibody-drug conjugate that targets the TROP2 receptor, which is often overexpressed on the surface of lung cancer cells, and delivers a drug that kills cells by disrupting DNA replication. TROP2 overexpression has been implicated in resistance to EGFR-directed therapy.
This is the first lung cancer indication for datopotamab deruxtecan-dlnk, which was previously approved to treat certain breast cancers. Datopotamab deruxtecan-dlnk is the first TROP2-directed therapeutic approved for lung cancer.
The accelerated approval is based on results from two multicenter trials: the single-arm phase II TROPION-Lung05 study and the open-label, randomized phase III TROPION-Lung01 study. Between the two trials, 114 patients with EGFR-mutated NSCLC who had been previously treated with an EGFR-targeted therapy and chemotherapy received datopotamab deruxtecan-dlnk.
Forty-five percent of patients experienced responses to the treatment, and in half of these patients, the responses lasted at least 6.5 months.
The recommended dose for datopotamab deruxtecan-dlnk is 6 mg/kg, not to exceed 540 mg for patients who weigh more than 90 kg. The therapy is administered intravenously once every three weeks until disease progression or unacceptable toxicity.
NSCLC is the most common type of lung cancer, which itself is the third most commonly diagnosed non-skin cancer in the United States. EGFR mutations are observed in about 20% to 50% of NSCLC cases. According to federal statistics, it was estimated that 226,650 individuals would be diagnosed with lung cancer and 124,730 would die of the disease in the United States in 2025.
The FDA rendered its decision on June 23, 2025. Accelerated approval means that continued approval may be contingent upon a confirmatory trial. Please check this FDA web page for information about any accelerated approvals in oncology that may have been subsequently withdrawn and are no longer FDA-approved. Check this resource for updated information on all therapeutics regulated by the FDA.