DATROWAY for Lung Cancer: A Simple Patient Guide

Learning about a new cancer treatment can feel overwhelming, especially when there are unfamiliar names, tests, and treatment plans involved. If you’ve come across DATROWAY® and want a simple explanation of what it is and how it may fit into lung cancer care, this guide breaks things down in an easy-to-understand way.

What Is DATROWAY?

DATROWAY® (datopotamab deruxtecan) is a newer type of targeted cancer medicine called an antibody–drug conjugate (ADC). It is designed to help deliver treatment more directly to cancer cells instead of affecting healthy cells in the same way traditional chemotherapy can. DATROWAY combines two parts: a monoclonal antibody called datopotamab and a cancer-fighting medicine called deruxtecan (DXd) linked together.¹

What Is DATROWAY Used For In Lung Cancer?

On June 23, 2025, the FDA granted accelerated approval to DATROWAY® (datopotamab deruxtecan-dlnk) for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who had already received prior EGFR-directed therapy and platinum-based chemotherapy.

In simple terms, DATROWAY is used for certain patients whose lung cancer has continued to progress after earlier targeted treatment and chemotherapy options. It is part of a newer group of targeted cancer medicines designed to deliver treatment more directly to cancer cells.^1,2

How Does DATROWAY Work?

DATROWAY works by first attaching to the TROP2 protein found on cancer cells. Once attached, the medicine enters the cancer cell and releases DXd, the cancer-fighting part of the treatment. This may lead to DNA damage, cancer cell death (apoptosis), and slowing of tumor growth. The goal of this targeted approach is to focus treatment more directly on cancer cells while aiming to reduce damage to surrounding healthy tissue.¹

What Is EGFR-Mutated Non-Small Cell Lung Cancer?

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and makes up around 80–85% of all lung cancer cases worldwide. Many patients are diagnosed at advanced stages, when treatment options may become more limited.³

In some patients with NSCLC, there are changes in a gene called EGFR (epidermal growth factor receptor). These are called EGFR mutations. EGFR mutations are seen in around 40% of Asian patients with NSCLC and around 20% of non-Asian patients.

These mutations can affect how cancer cells grow and survive, leading to uncontrolled cancer cell growth. Certain EGFR mutations, such as the EGFR T790M mutation, are also linked with resistance to some earlier EGFR-targeted treatments called EGFR tyrosine kinase inhibitors (TKIs). Understanding whether a patient has an EGFR mutation is important because it can help guide treatment decisions.³

Why EGFR Testing Matters Before DATROWAY Treatment

Before starting DATROWAY®, doctors first check whether the cancer has an EGFR mutation using a tumor or plasma test. This testing is important because DATROWAY is used for patients with EGFR-mutated non-small cell lung cancer.

The research also notes that EGFR testing can be done at any time after the initial diagnosis, and once EGFR mutation status has been confirmed, the test does not need to be repeated. Understanding EGFR mutation status helps guide treatment planning and determine whether DATROWAY may be an appropriate option.⁴

Who May Be Eligible For DATROWAY?

DATROWAY® may be considered for certain adult patients based on the type of cancer, specific test results, and prior treatments received. This includes:⁴

 - Adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have already received EGFR-directed therapy and platinum-based chemotherapy.

 - Adults with unresectable or metastatic HR-positive, HER2-negative breast cancer who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

When Is DATROWAY Given During Lung Cancer Treatment?

DATROWAY® is given as an intravenous (IV) infusion once every 3 weeks, also called a 21-day cycle. For lung cancer, DATROWAY may be considered after patients have already received EGFR-directed therapy and platinum-based chemotherapy. Treatment is generally continued until disease progression or unacceptable toxicity.^2,4

DATROWAY Dosage: What Patients Should Know

The recommended dose for DATROWAY® is 6 mg/kg, up to a maximum of 540 mg for patients weighing 90 kg or more.

If a planned dose is delayed or missed, it should be given as soon as possible rather than waiting for the next scheduled cycle. The schedule may then be adjusted to continue maintaining a 3-week interval between doses.⁴

What Happens During A DATROWAY Infusion?

Before starting DATROWAY®, patients undergo an ophthalmic (eye) exam that may include visual acuity testing, slit lamp examination with fluorescein staining, intraocular pressure checks, and fundoscopy. These eye checks are also repeated annually during treatment, at the end of treatment, and whenever clinically needed.⁴

Patients also receive certain premedications and concomitant medicines before DATROWAY infusions as part of the treatment process. DATROWAY is given in a healthcare setting where cardiopulmonary resuscitation (CPR) medicines and equipment are available in case of infusion-related reactions.

During treatment, patients are monitored closely for infusion-related reactions. For the first 2 infusion cycles, monitoring continues for at least 1 hour after the infusion. If no infusion-related reactions occur, later infusions are generally followed by at least 30 minutes of monitoring.⁴

Common Side Effects Of DATROWAY

Several side effects have been reported in patients receiving DATROWAY®. Commonly reported side effects included:⁴

 - Stomatitis (mouth sores) – 71%

 - Nausea – 50%

 - Alopecia (hair loss) – 49%

 - Fatigue – 42%

 - Constipation – 31%

 - Musculoskeletal pain – 22%

 - Rash – 20%

 - Decreased appetite – 20%

 - COVID-19 – 19%

 - Cough – 18%

 - Vomiting – 16%

 - Dry eye – 13%

 - Infusion-related reactions – 13%

 - Headache – 13%

 - Diarrhea – 12%

 - Pruritus (itching) – 12%

 - Keratitis – 12%

 - Shortness of breath (dyspnea) – 11%

Serious Side Effects And Warning Signs

DATROWAY® may sometimes cause serious side effects that require close monitoring during treatment.⁴

 - Interstitial lung disease (ILD)/pneumonitis: In patients with NSCLC, ILD/pneumonitis occurred in 7% of patients, including some severe and fatal cases. Symptoms may include cough, fever, and shortness of breath. The median time to onset was 1.4 months.

 - Eye-related side effects: Ocular adverse reactions occurred in 36% of patients. Common problems included dry eye (17%), keratitis (14%), increased tearing, blurred vision, and conjunctivitis.

 - Stomatitis (mouth sores/oral mucositis): Reported in 63% of patients, including 8% with Grade 3 events. The median time to first onset was 0.5 months.

 - Infusion-related precautions: Patients are monitored during and after infusions for possible infusion-related reactions.

 - Embryo-fetal toxicity: DATROWAY may cause harm during pregnancy. Patients of reproductive potential are advised to use effective contraception during treatment and for a period after the last dose.

Patients are advised to contact their healthcare provider if they develop new or worsening symptoms during treatment.

What Is Interstitial Lung Disease Or Pneumonitis?

Interstitial lung disease (ILD) is a broad term used for around 200 different lung conditions that can cause inflammation and scarring in the lungs. Over time, this scarring may make it harder for the lungs to work properly. Common symptoms linked with ILD can include:

 - Shortness of breath (dyspnoea)

 - Cough

 - Low oxygen levels (hypoxia)

 - Reduced lung function and mobility

ILD can develop for different reasons, including exposure to:

 - Mold, birds, or other organic particles (hypersensitivity pneumonitis)

 - Silica dust or asbestos fibers

 - Certain environmental or occupational irritants

 - Some medicines or autoimmune conditions

Long-term exposure to harmful airborne substances may trigger inflammation in lung tissue, which can later lead to fibrosis (scarring). One of the most aggressive forms is Idiopathic Pulmonary Fibrosis (IPF), a chronic and irreversible lung disease associated with progressive lung scarring. If left untreated, IPF has a reported median survival of around 3–5 years after diagnosis.

Eye-Related Side Effects Patients Should Know About

DATROWAY® may sometimes cause eye-related side effects, also called ocular adverse reactions. In studies, these were reported in 36% of patients receiving treatment. Common eye-related side effects included:⁴

 - Dry eye – 17%

 - Keratitis – 14%

 - Increased tearing

 - Blurred vision

 - Conjunctivitis

The median time to onset for eye-related side effects was 2.3 months after starting treatment. Because of this risk, patients may undergo regular eye examinations during treatment, including checks for vision changes and eye health.⁴

Mouth Sores And Oral Care During DATROWAY Treatment

DATROWAY® can sometimes cause stomatitis, which includes mouth sores, mouth ulcers, and oral mucositis. In studies, stomatitis was reported in 63% of patients receiving DATROWAY, including 8% with more severe Grade 3 events. The median time to first onset was around 0.5 months after starting treatment.⁴

To help manage or reduce mouth-related side effects, some patients used a steroid-containing mouthwash during treatment. Patients may also be advised to keep ice chips or ice water in the mouth during the infusion. If mouth sores develop, doctors may recommend increasing the use of mouthwash or adding other topical treatments depending on symptom severity.⁴

What To Ask Your Doctor Before Starting DATROWAY

Before starting DATROWAY®, it can help to have an open conversation with your doctor about the treatment process, monitoring, and what to expect during therapy. Some questions patients may want to ask include:

 - Why is DATROWAY being recommended for me?

 - How is DATROWAY given?

 - How often will I need treatment visits?

 - What side effects should I watch for?

 - Will I need regular eye checks or other monitoring?

 - What should I do if I notice new symptoms during treatment?

 - Are there any medicines or supplements I should mention before starting treatment?

 - Will treatment affect my daily routine or activities?

 - What support resources are available during treatment?

 - Who should I contact if I have concerns between appointments?

Final Thoughts

DATROWAY® is a newer targeted treatment option being used for certain patients with EGFR-mutated non-small cell lung cancer who have already received earlier therapies. Understanding how the treatment works, when it is used, possible side effects, and the importance of monitoring may help patients and caregivers feel more prepared during the treatment journey.²˒⁴

FAQs

 - What is DATROWAY used for in lung cancer?
DATROWAY is used for certain adults with locally advanced or metastatic EGFR-mutated NSCLC after prior EGFR-directed therapy and platinum-based chemotherapy.²

 - Who can receive DATROWAY for lung cancer?
Adults with EGFR-mutated non-small cell lung cancer who have already received specific earlier treatments may be eligible for DATROWAY.²˒⁴

 - Why do I need EGFR testing before DATROWAY?
EGFR testing helps confirm whether the cancer has an EGFR mutation, which is important before starting DATROWAY.⁴

 - Can DATROWAY cause lung inflammation?
Yes, DATROWAY may cause interstitial lung disease (ILD) or pneumonitis, including some severe cases.⁴

References

 - Mobashir M, Tarique H, Ahmad S, et al. Datopotamab deruxtecan: a new era in targeted therapy for metastatic breast cancer. Ann Med Surg (Lond). 2025;87(11):6942-6943. Published 2025 Sep 12. doi:10.1097/MS9.0000000000003857

 - U.S. Food and Drug Administration. FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer. Published June 23, 2025. Accessed May 22, 2026. FDA approval announcement

 - Tian Z, Cen L, Wei F, et al. EGFR mutations in non-small cell lung cancer: Classification, characteristics and resistance to third-generation EGFR-tyrosine kinase inhibitors (Review). Oncol Lett. 2025;30(2):375. Published 2025 Jun 2. doi:10.3892/ol.2025.15121

 - DATROWAY PI

 - Althobiani MA, Russell AM, Jacob J, et al. Interstitial lung disease: a review of classification, etiology, epidemiology, clinical diagnosis, pharmacological and non-pharmacological treatment. Front Med (Lausanne). 2024;11:1296890. Published 2024 Apr 18. doi:10.3389/fmed.2024.1296890

Note:

The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment.

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