Last reviewed 2026-04-20 · How we verify

DATOPOTAMAB DERUXTECAN

Datopotamab deruxtecan is a marketed drug for locally advanced or metastatic EGFR-mutated NSCLC, positioning it in a niche but critical segment of the oncology market. Its key strength lies in its unique mechanism of action, which differentiates it from existing treatments and offers a new therapeutic option for patients. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics and biosimilars.

At a glance

Approved indications

• Locally Advanced or Metastatic EGFR-Mutated NSCLC
• Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer

Common side effects

• Stomatitis
• Nausea
• Fatigue
• Alopecia
• Constipation
• Decreased appetite
• Rash
• Vomiting
• Musculoskeletal pain
• Decreased lymphocytes
• Decreased hemoglobin

Serious adverse events

• Serious adverse reactions (overall)
• COVID-19
• Stomatitis
• Pneumonia
• Fatal adverse reactions
• ILD/Pneumonitis
• Abnormal hepatic function

Key clinical trials

• Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) (PHASE3)
• Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) (PHASE2)
• Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) (PHASE3)
• Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations (PHASE3)
• Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (PHASE2)
• Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (PHASE2, PHASE3)
• A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) (PHASE3)
• SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• DATOPOTAMAB DERUXTECAN CI brief — competitive landscape report
• DATOPOTAMAB DERUXTECAN updates RSS · CI watch RSS