DATROWAY (datopotamab deruxtecan-dlnk): An Overview
Cancer is a group of diseases in which abnormal cells grow out of control. In many advanced cancers, traditional treatments may gradually stop working.1 Scientists are constantly developing newer therapies that more precisely target tumour cells while limiting harm to healthy tissues.2
DATROWAY (datopotamab deruxtecan-dlnk) is a newer cancer medicine called an antibody-drug conjugate (ADC). It’s approved to treat adults with certain advanced cancers that have progressed despite prior therapies.3
How DATROWAY Works (TROP2-directed ADC)
DATROWAY belongs to a class of medicines called TROP2-directed ADCs. It’s designed to deliver chemotherapy directly into cancer cells with a targeted approach.4
Here’s how it works4:
1. Targeting – DATROWAY includes an antibody that seeks out TROP2, a protein often found at high levels on certain cancer cells.
2. Delivery – Once bound to TROP2 on the cancer cell surface, the ADC enters the cell.
3.Killing the cell – Inside, the ADC releases a potent chemotherapy component (a topoisomerase I inhibitor) that damages the cancer cell’s DNA, blocking its ability to divide and survive.
By directing the chemotherapy payload specifically into cancer cells that express TROP2, DATROWAY aims to reduce the impact of chemotherapy on healthy cells.
Who Can Use DATROWAY
Breast cancer
DATROWAY is used in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body or cannot be removed by surgery after endocrine-based therapy and chemotherapy treatments have already been tried.4
Non-small cell lung cancer (NSCLC)
It is also used in adults with certain types of advanced lung cancer (EGFR-mutated NSCLC) that has spread or cannot be removed by surgery, after EGFR-directed therapy and platinum-based chemotherapy have been used.4
Who May Be Eligible (Testing and Prior Treatments)
To be considered for DATROWAY, several factors are important:
- Cancer type and markers: Your doctor may test your tumour for HRs and HER2 status for breast cancer or EGFR mutations for NSCLC. These help determine whether DATROWAY is an appropriate option.4
- Prior treatments: Eligibility usually requires that prior standard treatments have been tried. For breast cancer, this includes endocrine therapy and chemotherapy. For NSCLC, this includes EGFR-targeted treatments and platinum-based chemotherapy.4
Discuss all these details with your oncologist to understand if DATROWAY might be a fit for you.
DATROWAY Dosage and Infusion Schedule
DATROWAY is given as an intravenous (IV) infusion, meaning it is slowly delivered into a vein by a healthcare professional.4
- It is typically given once every 3 weeks.4
- The dose is based on your body weight and determined by your doctor.4
- Treatment usually continues as long as it is helping control the cancer and side effects remain manageable.4
Premedication and Supportive Care
Because DATROWAY can cause reactions and side effects, doctors usually give other medicines before the infusion, such as the following4:
- Antihistamines and fever reducers to lower infusion reactions.
- Anti-nausea drugs to reduce sickness.
- Lubricating eye drops and steroid mouthwash to help prevent or ease eye and mouth problems.
Your care team will guide supportive care based on your symptoms.
Common Side Effects of DATROWAY
Many patients experience side effects, including mouth sores (stomatitis), nausea and vomiting, fatigue, hair loss (alopecia), constipation, dry eyes, rash and changes in blood counts (e.g., low white cells or haemoglobin).4
Most side effects are manageable with supportive care but discuss any symptoms with your care team.
Serious Warnings
- Lung inflammation [interstitial lung disease (ILD)/pneumonitis]: DATROWAY can cause ILD or pneumonitis, which can be severe or even fatal. Be alert for new cough, shortness of breath, or fever.4
- Eye problems: Eye issues, including dry eye and keratitis, can occur. Report new or worsening eye pain, redness, changes in vision, or irritation.4
- Mouth ulcers/sores: Mouth ulcers and sores are common. If you experience mouth pain, swelling, or redness, inform your doctor immediately.4
These serious risks mean frequent check-ins with your care team are crucial.
Dose Reductions and Treatment Holds
If side effects occur, your doctor may4:
- Hold (pause) treatment until symptoms improve.
- Reduce the dose to a lower level if needed.
- Stop treatment if side effects are severe or life-threatening.
These adjustments aim to keep you safe while maintaining effectiveness.
Monitoring During Treatment
During treatment, your doctor may check4:
- Blood tests for blood counts
- Lung symptoms through exams and scans
- Eye exams before and during treatment
- Infusion reactions during and after each dose
Frequent monitoring helps catch side effects early and keeps treatment as safe as possible.
Accessing DATROWAY in India Through the Named Patient Program
DATROWAY is approved in certain countries for specific advanced cancers. However, availability may vary across regions in India. In situations where suitable local treatment options are limited, eligible patients may be able to access DATROWAY through the Named Patient Program (NPP).5
Under the NPP, a treating oncologist can request DATROWAY for an individual patient by submitting:
- Relevant medical records
- Confirmation of the required tumour characteristics (such as HR-positive/HER2-negative breast cancer or EGFR-mutated NSCLC)
- Clinical justification for use
This process may involve regulatory approvals and coordinated import before the medicine is supplied to the treating hospital or cancer centre.
Support services such as Rx4U may assist patients and caregivers with documentation, coordination with healthcare providers, and managing import and delivery logistics. This can help streamline the process and reduce administrative delays.
Final Takeaway
- DATROWAY is approved for certain adults with advanced HR-positive, HER2-negative breast cancer.
- It is also approved for certain adults with locally advanced or metastatic EGFR-mutated NSCLC.
- Biomarker testing (such as HR, HER2, or EGFR mutation testing) helps determine whether DATROWAY is appropriate.
- In India, access may be possible through the Named Patient Program with physician approval.
Frequently Asked Questions:
1. Can DATROWAY be used during pregnancy?
DATROWAY can cause harm to an unborn baby.4
Women who are pregnant or planning to become pregnant should inform their doctor. Effective contraception is recommended during treatment and for a period after the last dose. Men with partners who can become pregnant should also discuss contraception with their doctor.4
2. Can I breastfeed while receiving DATROWAY?
Breastfeeding is not recommended during treatment with DATROWAY and for some time after the final dose. It is not known whether the medicine passes into breast milk and could harm a baby. Speak with your doctor about when it may be safe to resume breastfeeding.4
Medical Disclaimer
This information is provided for educational purposes only and is not a substitute for professional medical advice. DATROWAY should only be taken under the guidance of a qualified healthcare provider. Patients should always consult their doctor or pharmacist for advice on diagnosis, treatment, and medication use, and should not make changes to their prescribed therapy without medical supervision.
References:
1. Zafar A, Khatoon S, Khan MJ, Abu J, Naeem A. Advancements and limitations in traditional anti-cancer therapies: a comprehensive review of surgery, chemotherapy, radiation therapy, and hormonal therapy. Discov Oncol. 2025;16(1):607. doi:10.1007/s12672-025-02198-8
2. Zhou Z, Li M. Targeted therapies for cancer. BMC Med. 2022;20(1):90. doi:10.1186/s12916-022-02287-3
3. Royce M, Shah M, Zhang L, et al. FDA approval summary: datopotamab deruxtecan-dlnk for treatment of patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer. Clin Cancer Res. 2025;31(21):4405-4411. doi:10.1158/1078-0432.CCR-25-1388
4. Prescribing information. Daiichi Sankyo, Inc.; 2025. Accessed February 24, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761464s000lbl.pdf
5. Patil S. Early access programs: benefits, challenges, and key considerations for successful implementation. Perspect Clin Res. 2016;7(1):4-8. doi:10.4103/2229-3485.173779
Note:
This information is provided for educational purposes only and is not a substitute for professional medical advice. Datroway should only be taken under the guidance of a qualified healthcare provider. Patients should always consult their doctor or pharmacist for advice on diagnosis, treatment, and medication use, and should not make changes to their prescribed therapy without medical supervision.
Disclaimer:
Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import.
