Datopotamab deruxtecan
- Medical Review: Sara Hurvitz, MD

Datopotamab deruxtecan (Datroway), sometimes called Dato DXd, is a targeted therapy that treats metastatic hormone receptor-positive, HER2-negative breast cancer.
Datopotamab deruxtecan is an antibody-drug conjugate. This means:
- It combines an antibody and a chemotherapy to target and treat cancer.
- The antibody directs the treatment toward certain proteins on cancer cells.
- The chemotherapy then kills those cancer cells.
The Food and Drug Administration approved datopotamab deruxtecan for breast cancer treatment in January 2025. It based the approval on results from the TROPION-Breast01 trial.
Datopotamab deruxtecan is approved to treat breast cancer with certain features:
- It is hormone receptor-positive and HER2-negative.
- It is metastatic. Or it is locally advanced and not able to be removed with surgery.
- The locally advanced or metastatic breast cancer has already been treated with hormonal therapy and chemotherapy.
The antibody in datopotamab deruxtecan acts like cells in your body that attack diseases. It targets Trop-2, a protein found in breast cancer cells. The antibody may limit the damage to healthy cells by bringing the chemotherapy directly to the cancer cells. Another FDA-approved antibody-drug conjugate, sacituzumab govitecan (Trodelvy) also treats metastatic hormone receptor-positive, HER2-negative breast cancer.
How datopotamab deruxtecan works
Datopotamab deruxtecan is an antibody-drug conjugate. This targeted therapy and others like it combine a chemotherapy with an antibody. The antibody acts like cells in your body that attack diseases. The antibody delivers the chemotherapy directly to the cancer cells.
The antibody in this treatment, datopotamab, targets a protein called Trop-2. The Trop-2 protein is present in normal cells. It signals them to grow and multiply. But many breast cancer cells make more of the protein than normal cells do.
The other part of this treatment is a chemotherapy drug called deruxtecan, or DXd. The datopotamab attaches to the Trop-2 proteins on cancer cells. The datopotamab then delivers the deruxtecan into the cancer cells and destroys them. It may also destroy nearby cancer cells and other cells that may be helping the cancer grow.
In a phase III trial:
- Datopotamab deruxtecan led to people going longer without cancer growing than those treated with chemotherapy. They lived an average of 6.9 months without cancer growth in the trial.
- People given chemotherapy lived 4.9 months without cancer growth.
- Datopotamab deruxtecan lowered the risk of cancer growing or spreading by 37% compared with chemotherapy.
- Survival wasn’t yet shown to be improved, but long-term follow-up is ongoing.
Who gets datopotamab deruxtecan?
Datopotamab deruxtecan is available for certain people with locally advanced or metastatic breast cancer. Your doctor may recommend it if you have cancer that meets all of these requirements:
- The cancer is hormone receptor-positive and HER2-negative.
- The cancer is metastatic or locally advanced and can’t be removed by surgery.
- You have been given hormonal therapy and chemotherapy since being diagnosed with advanced or metastatic breast cancer.
How datopotamab deruxtecan is given
The datopotamab deruxtecan schedule is one treatment, given by vein, once every three weeks.
The first infusion lasts 90 minutes. After the infusion, you will stay at your treatment center for 1 hour to see if there is a negative reaction. If there are no reactions, future infusions will take 30 minutes.
You should not wear contacts on treatment days unless instructed by your doctor. You can hold ice chips in your mouth during treatment to help prevent mouth sores, a common side effect.
Ask your doctor for any other directions to be ready for your appointment.
Treatment with datopotamab deruxtecan will continue until the cancer grows or spreads or you are no longer able to tolerate the side effects.
Side effects and things to remember
Datopotamab deruxtecan comes with warnings for certain side effects that can be severe.
- Mouth sores. Inflammation of the mouth or mouth sores are common side effects. They may be painful and can become severe. Let your healthcare team know right away if you have mouth problems such as pain, swelling, redness, ulcers, or sores.
- Eye problems. This treatment has been associated with problems in the eyes, including dryness. It may also cause the clear tissue in front of the eye to become inflamed. Let your healthcare team know if you experience dryness, irritation, swelling, redness, pain, or other changes to your eyes or sight. This can include the feeling that there is something in your eye.
- Lung effects. Inflammation of the lungs, called pneumonitis, or interstitial lung disease caused by treatment can become fatal if left untreated. Tell your healthcare team immediately if you have any problems with your lungs or breathing, including cough, shortness of breath, fever, chest tightness, and wheezing.
Common side effects
Common side effects of treatment with datopotamab deruxtecan include:
- Mouth sores
- Nausea and vomiting
- Fatigue
- Hair loss
- Constipation
- Dry eye
- An inflammation of the cornea called keratitis
- Rash
- Decreased appetite
- Cough
- Stomach pain
- Diarrhea
Paying for datopotamab deruxtecan
Datopotamab deruxtecan is a Food and Drug Administration-approved medicine. Many health insurance policies cover treatments based on their approved use. However, your insurance plan decides what treatments it will cover. Here are some things to keep in mind:
- Your insurer may require that your doctor get an approval from your insurance company before you can have the treatment. This is called prior authorization. It may also be called precertification or preauthorization.
- You may also be responsible for part of the cost of covered treatments.
- You can call your insurance company to learn what your policy covers.
- You can also ask your healthcare team for a referral to a financial counselor or hospital social worker who can help you learn more about your coverage.
- Some programs help pay for out-of-pocket costs. The makers of datopotamab deruxtecan (brand name Datroway) offer a patient savings program for people with private insurance. They also have patient assistance programs for people with no insurance or with government health coverage, such as Medicare. Visit datroway4u.com to learn more about these programs and other groups that may offer financial assistance.
LBBC offers information and other resources to help you understand your options when paying for breast cancer care. Visit Financial matters to learn more.
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- stent
- stereotactic biopsy
- stereotactic radiosurgery
- sterile
- sternum
- steroid
- stress
- strontium
- study agent
- subcutaneous
- subcutaneous port
- subjective improvement
- subset analysis
- supplemental nutrition
- supplementation
- support group
- supportive care
- supraclavicular lymph node
- surgeon
- surgery
- surgical biopsy
- surgical menopause
- surgical oncologist
- survival rate
- symptom
- symptom management
- symptomatic
- synergistic
- synthetic
- syringe
- systemic
- systemic chemotherapy
- systemic disease
- systemic therapy
- TAC regimen
- tai chi
- tailored intervention
- talk therapy
- tamoxifen
- targeted therapy
- taxane
- Taxol
- Taxotere
- Tc 99m sulfur colloid
- technician
- terminal disease
- therapeutic
- therapeutic touch
- therapy
- thermography
- thiethylperazine
- thiotepa
- third-line therapy
- thrush
- time to progression
- tinnitus
- tissue
- tissue flap reconstruction
- TNM staging system
- tomography
- tomotherapy
- topical
- topical chemotherapy
- topoisomerase inhibitor
- total estrogen blockade
- total mastectomy
- total nodal irradiation
- total parenteral nutrition
- toxic
- toxicity
- tracer
- traditional acupuncture
- tranquilizer
- transdermal
- transfusion
- transitional care
- translational research
- trastuzumab
- trauma
- treatment field
- trigger
- trigger point acupuncture
- triple-negative breast cancer
- tumescent mastectomy
- tumor
- tumor antigen vaccine
- tumor board review
- tumor burden
- tumor debulking
- tumor load
- tumor marker
- tumor volume
- Tykerb
- ulcer
- ulceration
- ultrasound-guided biopsy
- ultrasound/ultrasonography
- ultraviolet radiation therapy
- uncontrolled study
- undifferentiated
- unilateral
- unilateral salpingo-oophorectomy
- unresectable
- unresected
- upstaging
- urticaria
- VACB
- vaccine therapy
- vacuum-assisted biopsy or vacuum-assisted core biopsy
- Valium
- vancomycin
- vandetanib
- vascular endothelial growth factor-antisense oligonucleotide
- vascular endothelial growth factor receptor tyrosine kinase inhibitor
- vein
- Velban
- venipuncture
- venous sampling
- Versed
- vertebroplasty
- vinorelbine
- vital
- vomit
- watchful waiting
- wedge resection
- Wellcovorin
- Western medicine
- WGA study
- white blood cell
- whole cell vaccine
- whole genome association study
- wide local excision
- wire localization
- wound
- X-ray therapy
- Xanax
- Xeloda
- xerostomia
- Xgeva
- yoga
- ziconotide
- Zinecard
- Zofran
- zoledronic acid
- Zoloft
- Zometa
Living Beyond Breast Cancer is a national nonprofit organization that seeks to create a world that understands there is more than one way to have breast cancer. To fulfill its mission of providing trusted information and a community of support to those impacted by the disease, Living Beyond Breast Cancer offers on-demand emotional, practical, and evidence-based content. For over 30 years, the organization has remained committed to creating a culture of acceptance — where sharing the diversity of the lived experience of breast cancer fosters self-advocacy and hope. For more information, learn more about our programs and services.