Datroway: Uses, Dosage & Side Effects

A TROP2-directed antibody-drug conjugate (ADC) for hormone receptor-positive, HER2-negative metastatic breast cancer in adults who have received prior endocrine and systemic therapy

Rx TROP2-Directed ADC
Active Ingredient
Datopotamab deruxtecan
Available Forms
Powder for concentrate for solution for infusion
Strength
100 mg per vial
Manufacturer
Daiichi Sankyo

Datroway (datopotamab deruxtecan, also known as Dato-DXd) is a TROP2-directed antibody-drug conjugate (ADC) used to treat adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body or cannot be surgically removed. It is prescribed for patients who have previously received endocrine-based therapy and at least one additional systemic therapy for unresectable or metastatic disease. Datroway works by combining a monoclonal antibody that targets the TROP2 protein on cancer cells with a potent topoisomerase I inhibitor (DXd), delivering the anticancer payload directly to TROP2-expressing tumor cells. The drug was developed by Daiichi Sankyo and is administered as an intravenous infusion in a hospital or clinic setting.

Quick Facts: Datroway

Active Ingredient
Datopotamab deruxtecan
Drug Class
TROP2-Directed ADC
Route
Intravenous Infusion
Common Uses
HR+/HER2− Breast Cancer
Dosing Schedule
6 mg/kg Q3W
Prescription Status
Rx Only

Key Takeaways

  • Datroway (datopotamab deruxtecan) is a TROP2-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor (DXd) directly to TROP2-expressing cancer cells, causing targeted DNA damage and cell death while aiming to limit systemic toxicity.
  • It is approved for adults with HR-positive, HER2-negative unresectable or metastatic breast cancer who have previously received endocrine-based therapy and at least one additional line of systemic treatment.
  • Interstitial lung disease (ILD) is a serious and potentially fatal risk; patients must be monitored for respiratory symptoms including cough, shortness of breath, and fever throughout treatment.
  • Ocular side effects (dry eyes, keratitis, blurred vision) and oral mucositis are very common; preventive measures including preservative-free lubricating eye drops and alcohol-free mouthwash should be used from the start of treatment.
  • Women must use effective contraception for at least 7 months and men for at least 4 months after the last dose; patients should discuss fertility preservation before starting treatment.

What Is Datroway and What Is It Used For?

Quick Answer: Datroway (datopotamab deruxtecan) is a TROP2-directed antibody-drug conjugate used to treat adults with hormone receptor-positive, HER2-negative breast cancer that has spread or cannot be removed surgically. It works by targeting the TROP2 protein on cancer cells and delivering a potent cell-killing agent directly inside them.

Datroway contains the active substance datopotamab deruxtecan, a next-generation antibody-drug conjugate (ADC) that belongs to a growing class of precision oncology therapies. ADCs are designed to combine the targeting specificity of a monoclonal antibody with the cell-killing power of a cytotoxic drug, delivering treatment directly to cancer cells while aiming to reduce damage to healthy tissue. The ADC concept represents one of the most significant advances in cancer therapy in recent decades, and Datroway is among the latest additions to this rapidly evolving therapeutic class.

The structure of Datroway consists of three distinct components: a humanized monoclonal antibody called datopotamab, which recognizes and binds to the TROP2 protein on the surface of cancer cells; a cleavable tetrapeptide-based linker that connects the antibody to the drug payload; and the payload itself, a potent topoisomerase I inhibitor known as DXd (an exatecan derivative). When the datopotamab antibody binds to TROP2 on the cancer cell surface, the entire ADC complex is internalized into the cell. Inside the cell, lysosomal enzymes cleave the linker, releasing DXd. Once free, DXd binds to the topoisomerase I-DNA complex and stabilizes it, preventing the normal relegation of single-strand DNA breaks. This leads to accumulation of DNA damage during replication, causing double-strand DNA breaks, replication fork collapse, and ultimately apoptotic cell death.

TROP2 (trophoblast cell-surface antigen 2, also known as TACSTD2) is a transmembrane glycoprotein that is overexpressed on the surface of many solid tumors, including a large proportion of breast cancers. In normal tissues, TROP2 expression is present at lower levels in certain epithelial cells, but in cancer it is frequently upregulated and has been associated with increased tumor proliferation, migration, and invasiveness. The high prevalence of TROP2 expression across breast cancer subtypes makes it an attractive therapeutic target. In HR-positive, HER2-negative breast cancer specifically, TROP2 is expressed in the majority of tumors, providing a strong rationale for TROP2-directed therapy in this patient population.

Datroway is approved for the treatment of adults who have been diagnosed with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic disease) or cannot be surgically removed (unresectable disease). Specifically, it is indicated for patients who have previously received endocrine-based therapy (such as aromatase inhibitors, tamoxifen, or fulvestrant, often in combination with CDK4/6 inhibitors) and at least one additional systemic therapy for their unresectable or metastatic disease. This positions Datroway as a later-line treatment option for patients whose cancer has progressed despite multiple prior therapies.

The approval of Datroway was supported by the results of the TROPION-Breast01 phase III randomized clinical trial, which demonstrated a statistically significant improvement in progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with HR+/HER2− metastatic breast cancer. The trial enrolled patients who had received one to two prior lines of chemotherapy for metastatic disease and had previously been treated with endocrine therapy and a CDK4/6 inhibitor. These results established Datroway as a meaningful new treatment option in a patient population with significant unmet medical need, where disease often progresses through available therapies and effective treatment options become increasingly limited.

TROP2-Targeted Therapy

Datroway is designed to selectively target cancer cells that express the TROP2 protein on their surface. By delivering the topoisomerase I inhibitor DXd directly to these cells, the drug aims to maximize anticancer activity at the tumor site. Additionally, because the released DXd is membrane-permeable, it can also diffuse into and affect neighboring tumor cells (a phenomenon known as the “bystander effect”), potentially enhancing efficacy even in tumors with heterogeneous TROP2 expression.

What Should You Know Before Receiving Datroway?

Quick Answer: Do not receive Datroway if you are allergic to datopotamab deruxtecan or any of its ingredients. Inform your doctor about all medical conditions, especially any history of lung disease, eye problems, liver issues, or if you are pregnant or breastfeeding. Both men and women must use effective contraception during treatment.

Contraindications

Before starting treatment with Datroway, it is essential to understand situations in which the drug must not be used. The primary contraindication is known hypersensitivity (allergy) to datopotamab deruxtecan or any of the excipients in the formulation, which include L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbat 80. If you are unsure whether you are allergic to any of these ingredients, discuss this with your doctor or nurse before receiving treatment.

Polysorbat 80, in particular, is an excipient that can occasionally cause allergic reactions in susceptible individuals. Each vial of Datroway contains 1.5 mg of polysorbat 80. If you have any known allergies, make sure to inform your healthcare team before treatment begins.

Warnings and Precautions

In addition to the risk of ILD, there are several other important warnings and precautions to be aware of during treatment with Datroway:

  • Ocular (eye) toxicity: Datroway can cause significant eye problems, including keratitis (inflammation of the cornea), dry eyes, increased tear production, photosensitivity (light sensitivity), and changes in vision. Patients are strongly advised to use preservative-free lubricating eye drops multiple times daily to prevent dry eyes and other ocular problems, starting from the beginning of treatment. Contact lenses should not be worn during treatment. If you develop any eye symptoms, including dry eyes, excessive tearing, light sensitivity, or vision changes, inform your doctor or nurse promptly. Your doctor may refer you to an ophthalmologist (eye specialist) if needed.
  • Oral mucositis (stomatitis): Mouth sores and ulcers are very common with Datroway and can cause significant pain and discomfort. In addition to maintaining good oral hygiene and following dietary recommendations, your doctor will recommend an alcohol-free mouthwash to be used four times daily. This mouthwash may contain steroids. If you develop mouth pain, discomfort, or open sores in the mouth, inform your healthcare team immediately. Follow your doctor’s instructions on using mouthwash to prevent or manage stomatitis.
  • Hepatotoxicity: If you have pre-existing liver problems, your doctor may need to monitor you more closely during treatment, as liver function may be affected.
  • Hematological toxicity: Datroway can cause decreases in blood cell counts, including anemia (low red blood cells) and neutropenia (low white blood cells that fight infection). Your doctor will perform regular blood tests to monitor for these changes.

Pregnancy and Breastfeeding

Contraception Requirements

Women of childbearing potential must use effective contraception during treatment with Datroway and for at least 7 months after the last dose. Men whose partners can become pregnant must use effective contraception during treatment and for at least 4 months after the last dose. Discuss the best contraceptive methods with your doctor before starting treatment.

Datroway is not recommended during pregnancy because the active component may cause harm to the developing fetus. If you are pregnant, think you may be pregnant, or are planning to become pregnant, tell your doctor immediately before or during treatment. The mechanism of action of DXd (causing DNA damage) poses a risk of teratogenicity and embryotoxicity based on the pharmacological properties of the drug.

Breastfeeding is not recommended during treatment with Datroway and for at least 1 month after the last dose. It is not known whether datopotamab deruxtecan or its metabolites are excreted in human breast milk. Given the potential for serious adverse reactions in breastfed infants, breastfeeding should be discontinued during treatment.

Both men and women should seek counseling about fertility preservation options before starting treatment with Datroway, as the drug may reduce fertility. Options such as egg freezing or sperm banking should be discussed with your healthcare team before the first dose.

Children and Adolescents

Datroway is not recommended for use in individuals under 18 years of age. There is no information available on the efficacy or safety of this medicine in the pediatric population. The approved indication (HR+/HER2− metastatic breast cancer) is extremely rare in children and adolescents.

Driving and Operating Machinery

Datroway may impair your ability to drive or operate machinery. Exercise caution if you feel tired (fatigue is a very common side effect) or if you experience visual disturbances, as these can affect your ability to perform tasks requiring concentration and clear vision. If you are affected, do not drive or use machinery until these symptoms resolve.

How Does Datroway Interact with Other Drugs?

Quick Answer: Inform your doctor about all medications you are taking. While formal drug interaction studies with Datroway are limited, caution is advised with strong CYP3A4 inhibitors and inducers, as the DXd payload is metabolized by CYP3A4 enzymes. OATP1B1/OATP1B3 substrates may also be affected.

Before starting Datroway, tell your doctor or nurse about all medicines you are currently taking, have recently taken, or might take, including prescription medications, over-the-counter products, vitamins, and herbal supplements. Understanding potential drug interactions is important for your safety during treatment.

The DXd payload released from Datroway is metabolized primarily by CYP3A4 enzymes in the liver. While the clinical significance of drug interactions with Datroway has not been fully characterized in formal interaction studies, the following theoretical interactions should be considered based on the pharmacological properties of the drug:

Potential Interactions

Potential Drug Interactions with Datroway
Interacting Drug / Class Type Clinical Significance
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) Pharmacokinetic May increase DXd exposure, potentially increasing the risk and severity of adverse effects. Use with caution; dose modification may be considered.
Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John’s wort) Pharmacokinetic May decrease DXd exposure, potentially reducing efficacy. Avoid concomitant use if possible.
OATP1B1/OATP1B3 substrates (e.g., statins such as rosuvastatin, atorvastatin) Pharmacokinetic DXd may inhibit OATP1B transporters, potentially increasing exposure of co-administered substrates. Monitor for toxicity of substrate drugs.
Myelosuppressive agents (other chemotherapy drugs) Pharmacodynamic Additive risk of bone marrow suppression (neutropenia, anemia). Monitor blood counts more frequently.
Live vaccines Immunological Avoid live or live-attenuated vaccines during treatment due to potential immunosuppressive effects. Inactivated vaccines may be used but response may be diminished.

It is important to note that formal clinical drug interaction studies for Datroway are ongoing, and the interactions listed above are based on the known pharmacological properties of the DXd payload and the ADC platform. Your oncologist will carefully review all of your current medications before initiating treatment and throughout the course of therapy.

Tell Your Healthcare Team

Always inform your doctor, nurse, or pharmacist about all medications you are taking, including over-the-counter medicines, vitamins, and herbal supplements, before each infusion of Datroway. Some interactions may require dose adjustments, additional monitoring, or avoidance of certain combinations.

What Is the Correct Dosage of Datroway?

Quick Answer: The recommended dose of Datroway is 6 mg per kilogram of body weight, administered as an intravenous infusion once every three weeks. The first infusion takes 90 minutes; subsequent infusions may be given over 30 minutes if the first was well tolerated.

Datroway is administered in a hospital or outpatient clinic by a healthcare professional experienced in the use of anticancer medicines. It is given as a drip (infusion) into a vein. Your doctor or nurse will calculate the correct dose based on your body weight and determine how many treatment cycles you will receive.

Adults

Standard Dosing

Dose: 6 mg per kilogram of body weight

Frequency: Once every 3 weeks (21-day cycle)

Route: Intravenous infusion

First infusion: 90 minutes

Subsequent infusions: 30 minutes (if the first infusion was well tolerated)

Monitoring: 30 minutes of observation after each infusion

Before each infusion, your healthcare team may give you pre-medications to help prevent nausea, vomiting, and infusion-related reactions. These may include anti-emetics (anti-nausea medications), corticosteroids, and/or antihistamines. Your doctor will determine the appropriate pre-medication regimen based on your individual risk factors and response to previous cycles.

During the treatment period, your healthcare team will also recommend an alcohol-free mouthwash for regular use (four times daily) to help prevent oral mucositis. Additionally, you should apply preservative-free lubricating eye drops multiple times daily and avoid wearing contact lenses throughout the entire course of treatment.

Datroway Dosing Summary
Parameter Details
Recommended dose 6 mg/kg body weight
Cycle length Every 3 weeks (Q3W)
First infusion duration 90 minutes
Subsequent infusion duration 30 minutes (if first infusion tolerated)
Post-infusion monitoring 30 minutes
Administration route Intravenous infusion only
Reconstitution 100 mg vial reconstituted with 5 mL water for injection (20 mg/mL)
Dilution Diluted in 100 mL 5% glucose solution

Children and Adolescents

Datroway is not recommended for persons under 18 years of age. The safety and efficacy in pediatric patients have not been established, and the approved indication is an adult cancer type.

Elderly Patients

No specific dose adjustment is required for elderly patients. However, older adults may be more susceptible to certain side effects, particularly fatigue, hematological toxicity, and ocular adverse events. Your doctor will monitor you closely and may adjust the dose or delay treatment if necessary based on your individual tolerance.

Dose Modifications

Your doctor may need to reduce the dose, delay a treatment cycle, or permanently discontinue Datroway depending on the type and severity of side effects you experience. Specific dose modification guidelines exist for interstitial lung disease, ocular toxicity, oral mucositis, neutropenia, and other adverse events. If you experience symptoms during the infusion (infusion-related reactions), your doctor may slow the infusion rate, pause the infusion temporarily, or stop it altogether depending on the severity of the reaction.

Missed Dose

If you miss a scheduled appointment to receive Datroway, contact your doctor or treatment clinic immediately to reschedule. It is very important not to miss any doses of this medicine. Your doctor will determine the appropriate timing for your next infusion based on when the missed dose occurred and your clinical condition.

Stopping Treatment

Do not stop receiving Datroway without first discussing it with your doctor or nurse. Treatment decisions should always be made in consultation with your oncology team, who will weigh the benefits and risks of continuing therapy based on your response and tolerance. If you have questions about your treatment, do not hesitate to speak with your healthcare team.

What Are the Side Effects of Datroway?

Quick Answer: The most common side effects of Datroway include oral mucositis, nausea, fatigue, hair loss, constipation, vomiting, dry eyes, anemia, decreased appetite, and keratitis. Serious but less common side effects include interstitial lung disease (ILD) and severe neutropenia. Contact your doctor immediately if you develop breathing problems, fever, or severe mouth sores.

Like all medicines, Datroway can cause side effects, although not everyone will experience them. The frequency and severity of side effects can vary depending on the dose you receive and your individual health status. It is important to inform your doctor or nurse about any side effects you experience, including those not listed in this information, so that they can be managed appropriately.

Some side effects can become serious and potentially life-threatening. Contact your doctor or nurse immediately if you experience any of the following symptoms:

Side Effect Frequency Overview

Very Common

May affect more than 1 in 10 people

  • Oral mucositis / stomatitis (mouth sores and ulcers)
  • Keratitis (inflammation of the cornea)
  • Nausea
  • Fatigue (tiredness, exhaustion)
  • Hair loss (alopecia)
  • Constipation
  • Vomiting
  • Dry eyes
  • COVID-19
  • Anemia (low red blood cell count), as shown in blood tests
  • Decreased appetite
  • Elevated liver enzymes (aspartate aminotransferase / AST)
  • Skin rash
  • Diarrhea
  • Neutropenia (low levels of neutrophils, a type of white blood cell)
  • Elevated liver enzymes (alanine aminotransferase / ALT)

Common

May affect up to 1 in 10 people

  • Interstitial lung disease (ILD) / pneumonitis
  • Conjunctivitis (redness and discomfort of the eye)
  • Infusion-related reactions (fever, chills, itching, rash)
  • Increased tear production (epiphora)
  • Urinary tract infection
  • Dry skin
  • Dry mouth
  • Itching (pruritus)
  • Blepharitis (eyelid inflammation)
  • Shortness of breath (dyspnea)
  • Taste disturbances (dysgeusia)
  • Meibomian gland dysfunction
  • Skin hyperpigmentation (darkening)
  • Blurred vision
  • Lung infection (pneumonia)
  • Leukopenia (low white blood cell count)
  • Loss of eyelashes (madarosis)
  • Abnormal light sensitivity in the eyes
  • Sepsis (life-threatening bloodstream infection with fever, chills, and feeling unwell)

Uncommon

May affect up to 1 in 100 people

  • Decreased vision

Managing Side Effects

Many of the side effects associated with Datroway can be managed effectively with appropriate supportive care measures. Your healthcare team will provide guidance on preventing and managing side effects throughout your treatment. Key preventive measures include:

  • For eye problems: Use preservative-free lubricating eye drops multiple times daily, starting from the first day of treatment. Avoid wearing contact lenses. Report any eye symptoms promptly so your doctor can assess whether referral to an ophthalmologist is needed.
  • For mouth sores: Maintain good oral hygiene, use the prescribed alcohol-free mouthwash four times daily (which may contain steroids), follow dietary recommendations (avoid spicy, acidic, or rough-textured foods), and report any oral pain or open sores to your healthcare team.
  • For nausea and vomiting: Take anti-nausea medications as prescribed before and after each infusion. Eat small, frequent meals and stay hydrated.
  • For fatigue: Plan activities around periods of higher energy, prioritize rest, and engage in light physical activity as tolerated.
  • For low blood counts: Watch for signs of infection (fever, chills, sore throat) and report them immediately. Avoid contact with people who are ill. Your doctor will check blood counts regularly.

Your doctor may adjust your dose, delay treatment, or in some cases permanently discontinue Datroway if side effects become severe or unmanageable. Never attempt to manage serious side effects on your own – always contact your healthcare team for guidance.

How Should Datroway Be Stored?

Quick Answer: Datroway is stored and handled by healthcare professionals at the hospital or clinic where you receive treatment. It must be kept refrigerated at 2–8 °C, protected from light, and must not be frozen.

Datroway is stored by healthcare professionals at the hospital or clinic where you receive your treatment. You do not need to store this medicine at home, as it is administered as an intravenous infusion in a healthcare setting. The following storage information is provided for completeness and is primarily relevant to healthcare professionals:

  • Unopened vials: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
  • Reconstituted solution: Stable for up to 24 hours at 2°C to 8°C, protected from light. Must be discarded after 24 hours.
  • Diluted infusion solution: If not used immediately, may be stored at room temperature (up to 25°C) for up to 4 hours including reconstitution and infusion time, or at 2°C to 8°C for up to 24 hours protected from light. Do not freeze.
  • Light protection: Both the reconstituted solution and diluted infusion must be protected from light.
  • Keep out of the sight and reach of children.
  • Do not use after the expiry date stated on the carton and vial after “EXP.” The expiry date refers to the last day of that month.

Appropriate procedures for handling and disposal of cytotoxic and antineoplastic medicines must be followed. Healthcare professionals are responsible for properly disposing of any unused Datroway in accordance with local regulations. These measures help protect the environment.

What Does Datroway Contain?

Quick Answer: Datroway contains the active substance datopotamab deruxtecan (100 mg per vial). After reconstitution with 5 mL of water for injections, the solution contains 20 mg/mL. Inactive ingredients include L-histidine, L-histidine hydrochloride monohydrate, sucrose, and polysorbat 80.

Active Ingredient

The active substance is datopotamab deruxtecan. Each vial of powder for concentrate for solution for infusion contains 100 mg of datopotamab deruxtecan. After reconstitution with 5 mL of water for injections, each vial contains 5 mL of solution at a concentration of 20 mg/mL.

Inactive Ingredients (Excipients)

  • L-histidine
  • L-histidine hydrochloride monohydrate
  • Sucrose
  • Polysorbat 80 (1.5 mg per vial – see section on contraindications and warnings regarding potential allergic reactions)

Appearance and Packaging

Datroway is a white to yellowish-white lyophilized (freeze-dried) powder supplied in a clear, amber-colored glass vial sealed with a rubber stopper, aluminum seal, and plastic snap-off cap. Each carton contains 1 vial.

Reconstitution and Dilution (Healthcare Professionals)

Datroway contains a cytotoxic component and must be prepared and administered under the supervision of a physician experienced in the use of cytotoxic agents. Appropriate aseptic technique must be used during reconstitution and dilution.

  • Reconstitution: Each 100 mg vial is reconstituted by slowly injecting 5 mL of water for injections to yield a final concentration of 20 mg/mL. Gently swirl the vial until all contents are dissolved. Do not shake. The reconstituted solution should be clear and colorless to slightly yellow.
  • Dilution: The calculated volume of reconstituted solution is diluted in a 100 mL infusion bag containing 5% glucose solution. Do not use sodium chloride (saline) solution. PVC or polyolefin (polypropylene or ethylene-propylene copolymer) infusion bags are recommended.
  • Administration: Administer as an intravenous infusion using a 0.2-micron inline filter (PTFE, PES, or nylon 66). Do not administer as an intravenous push or bolus injection. Do not mix with or administer through the same infusion line as other medicinal products.
Marketing Authorization Holder

Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany. For further information about this medicine, contact the local representative of the Marketing Authorization Holder in your country.

Frequently Asked Questions About Datroway

Datroway (datopotamab deruxtecan) is used to treat adults with hormone receptor-positive (HR+), HER2-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be surgically removed. It is specifically indicated for patients who have previously received endocrine-based therapy and at least one additional systemic therapy for unresectable or metastatic disease. Datroway works by targeting the TROP2 protein on cancer cells and delivering a potent anticancer agent directly into them.

Datroway is administered as an intravenous (IV) infusion (drip) in a hospital or clinic by a healthcare professional experienced in the use of cancer medicines. It is not available as an oral medication. The recommended dose is 6 mg per kilogram of body weight, given once every three weeks. The first infusion takes approximately 90 minutes, and subsequent infusions may be given over 30 minutes if well tolerated. Patients are monitored for 30 minutes after each infusion.

Yes. Interstitial lung disease (ILD) and pneumonitis are known potential side effects of Datroway that occur in up to 1 in 10 patients. These conditions involve inflammation of the lungs and can be serious and potentially fatal. Symptoms include new or worsening cough, shortness of breath, fever, or difficulty breathing. Patients with a history of lung disease may be at increased risk. If you develop any respiratory symptoms during treatment, contact your doctor immediately. Your doctor will monitor your lung function and may need to temporarily or permanently discontinue treatment.

Datroway commonly causes ocular (eye) side effects, including dry eyes, keratitis (inflammation of the cornea), increased tearing, light sensitivity, and vision changes. Using preservative-free lubricating eye drops multiple times daily from the start of treatment helps protect the corneal surface and reduce the severity of these effects. Contact lenses should not be worn during treatment. If you develop significant eye symptoms, your doctor may refer you to an ophthalmologist for specialized care.

Oral mucositis (mouth sores) is one of the most common side effects of Datroway. To help prevent and manage mouth sores, your doctor will recommend using an alcohol-free mouthwash (which may contain steroids) four times daily from the start of treatment. Maintaining good oral hygiene is essential: brush your teeth gently with a soft toothbrush, avoid spicy, acidic, or rough-textured foods, stay well hydrated, and avoid alcohol and tobacco. If mouth sores develop, inform your healthcare team promptly, as dose adjustments may be needed for severe cases.

No. Datroway is not recommended during pregnancy because the active component (DXd) may cause harm to the developing fetus through its mechanism of DNA damage. Women of childbearing potential must use effective contraception during treatment and for at least 7 months after the last dose. Men whose partners can become pregnant should use effective contraception during treatment and for at least 4 months after the last dose. Breastfeeding should be avoided during treatment and for at least 1 month after the last dose. Patients should discuss fertility preservation (e.g., egg freezing, sperm banking) with their doctor before starting therapy.

References

  1. European Medicines Agency (EMA). Datroway (datopotamab deruxtecan) – Summary of Product Characteristics. EMA/2025. Available at: www.ema.europa.eu
  2. Bardia A, Jhaveri K, Kalinsky K, et al. “Datopotamab Deruxtecan in Previously Treated HR-Positive/HER2-Negative Metastatic Breast Cancer: Results From the Phase III TROPION-Breast01 Trial.” The New England Journal of Medicine. 2024. DOI: 10.1056/NEJMoa2314904
  3. European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Metastatic Breast Cancer. ESMO, 2024. Available at: www.esmo.org
  4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 2025. Available at: www.nccn.org
  5. World Health Organization (WHO). WHO Model List of Essential Medicines. WHO, 2023. Available at: www.who.int
  6. Goldenberg DM, Stein R, Sharkey RM. “The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target.” Oncotarget. 2018;9(48):28989–29006. DOI: 10.18632/oncotarget.25615
  7. British National Formulary (BNF). Datopotamab deruxtecan. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
  8. Daiichi Sankyo. Datroway (datopotamab deruxtecan) – Prescribing Information. 2025.

Editorial Team

This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, breast cancer, and clinical pharmacology.

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