Dato DXd (ADC) Approved by U.S. FDA for Lung Cancer
Dato DXd (datopotamab deruxtecan) has received U.S. FDA approval – a breakthrough milestone announced jointly by Daiichi Sankyo and AstraZeneca on June 23, 2025.
The drug is indicated for the treatment of adults with locally advanced or metastatic EGFR‑mutant NSCLC who have previously received EGFR‑targeted therapy and platinum‑based chemotherapy.
This marks the FDA’s first-ever approval of a TROP2-targeting therapy for EGFR‑mutant NSCLC, representing a significant breakthrough in lung cancer treatment.
🌍 Background
Lung cancer remains one of the most prevalent and deadly cancers worldwide, with NSCLC accounting for about 85% of cases.
For patients with NSCLC and EGFR-sensitive mutations, EGFR tyrosine kinase inhibitors (TKIs) are the standard first-line treatment, significantly improving progression-free survival and quality of life.
However, nearly all patients develop resistance eventually, often leaving them with limited and less effective treatment options after EGFR-TKIs and platinum chemotherapy fail.
🧬 About Dato DXd
Dato‑DXd is an antibody–drug conjugate (ADC) that targets TROP2, a transmembrane glycoprotein highly expressed in over 75% of NSCLC tumors.
The ADC combines a humanized anti‑TROP2 IgG1 monoclonal antibody with a cleavable tetrapeptide linker connected to the cytotoxic payload DXd (a derivative of SN‑38), enabling targeted delivery of the toxin to cancer cells while minimizing normal tissue damage.
📊 Dato DXd Clinical Data Highlights
- Pivotal Trials: Approval was based on pooled data from the TROPION‑Lung05 (Phase II) and supportive TROPION‑Lung01 (Phase III) studies
- Objective Response Rate (ORR) in previously treated EGFR‑mutant NSCLC patients: 45%
- Duration of Response (DoR): Not explicitly stated in the FDA announcement, but approval is based on both ORR and DoR
🛡️ Dato DXd Safety Profile
Dato‑DXd was generally well-tolerated. Treatment-related adverse events included:
- Mucosal inflammation, nausea, hair loss, fatigue, anemia, lymphopenia, constipation, elevated liver enzymes, and skin rash
- Most of which were grade 1–2 and manageable. Serious adverse events and treatment-related deaths were relatively low
🚀 What’s Next: “Chemo-Free” Strategy
Dato‑DXd launches Daiichi Sankyo and AstraZeneca’s “chemo-free” strategic initiative for NSCLC treatment. Two phase III trials are ongoing:
- TROPION‑Lung14: Evaluating Dato‑DXd plus osimertinib (first-line) in untreated EGFR‑mutant NSCLC.
- TROPION‑Lung15: Assessing Dato‑DXd alone or combined with osimertinib vs. platinum-doublet chemotherapy in post‑osimertinib progression
If successful, these trials could reshape first‑line and salvage therapy, offering precision, high efficacy, and reduced toxicity for NSCLC patients.
✅ Dato DXd Conclusion
The FDA approval of Dato‑DXd marks a significant therapeutic advance for EGFR‑resistant NSCLC.
With strong clinical efficacy (ORR ≈ 45%, DoR ~6–7 months), manageable safety, and ongoing adaptive trials, it paves the way toward a chemotherapy-sparing paradigm.
This milestone not only fulfills a substantial unmet need but also establishes a foundation for future ADC development in lung cancer.
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