Datroway (datopotamab deruxtecan-dlnk) for NSCLC and Breast Cancer Treatment – Guidelines+ Monograph

Datroway (datopotamab deruxtecan-dlnk) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of non-small-cell lung cancer and breast cancer in adults. Datroway was first approved in January 2025 for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy, and then later that year received approval for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Read on to learn more about Datroway, including its warnings and precautions, dosage and administration information, and more.

Medication Overview:

• Brand Name: Datroway
• Generic Name: datopotamab deruxtecan-dlnk
• Treatment for: Non-small cell lung cancer and breast cancer
• Manufacturer: Daiichi Sankyo
• Initial FDA Approval: January 2025

Warnings and Precautions:

• Interstitial Lung Disease (ILD) and Pneumonitis: Datroway can cause severe and fatal cases of ILD/pneumonitis. Monitor for new or worsening signs and symptoms of ILD/pneumonitis. If ILD/pneumonitis is suspected, withhold Datroway and initiate corticosteroids. Permanently discontinue Datroway in patients with confirmed Grade 2 or higher ILD/pneumonitis. 
• Ocular Adverse Reactions: Datroway can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. Monitor patients for ocular adverse reactions during treatment with Datroway. Advise patients to use preservative-free lubricating eye drops and to avoid using contact lenses during treatment with Datroway. Withhold, reduce the dose, or permanently discontinue Datroway based on the severity of ocular adverse reactions. Refer patients to an eye care professional for any new or worsening ocular signs and symptoms.
• Stomatitis/Oral Mucositis: Datroway can cause stomatitis, including mouth ulcers and oral mucositis. Advise patients to use a steroid-containing mouthwash when starting treatment and to hold ice chips or ice water in mouth during the infusion of Datroway. Withhold, reduce the dose, or permanently discontinue Datroway based on severity.
• Embryo-Fetal Toxicity: Datroway can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Dosage and Administration:

Reconstitute Datroway with sterile water for injection.

Dilute with 5% dextrose injection.

For intravenous infusion only. Do not administer as an intravenous push or bolus. DO NOT use sodium chloride injection, USP.

Premedicate to reduce the risk of infusion reaction and nausea and vomiting.

The recommended dosage of Datroway is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) given as an intravenous infusion once every three weeks. (21-day cycle) until disease progression or unacceptable toxicity.

Contraindications:

None.

Adverse Reactions:

The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with:

• EGFR-mutated NSCLC were stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash.
• HR-positive, HER2-negative breast cancer were stomatis, nausea, fatigue, decreased leukocyres, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, vomiting, increased ALT, keratitis, increased AST, and increased alkaline phosphatase.

Examples of datopotamab deruxtecan in Guidelines

Therapy for Stage IV Non-Small-Cell Lung Cancer with Driver Alterations

• American Society of Clinical Oncology (ASCO)
• February 2026
• “For patients whose disease has progressed on osimertinib and platinum chemotherapy, clinicians may offer datopotamab deruxtecan.”

Cancer During Pregnancy

• American Soceity of Clinical Oncology (ASCO)
• December 2025
• “Clinicians should generally avoid antibody-drug conjugates such as trastuzumab emtansine, trastuzumab deruxtecan, sacituzumab govitecan, mirvetuximab soravtansine, tisotumab vedotin, enfortumab vedotin, datopotamab deruxtecan, brentuximab vedotin, etc., during all trimesters of pregnancy due to concerns for fetal toxicity based on mechanism of action and lack of safety data.”

Please note: This article is current as of May 21, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.

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