Breast Cancer Treatments/Medical Treatments

New First-Line Treatment for Advanced TNBC Extends Survival Compared to Chemo

Written by Ted Samson

Posted on June 9, 2026

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FDA approval for new breast cancer treatment The U.S. Food and Drug Administration (FDA) has approved a new treatment option, datopotamab deruxtecan-dlnk (Datroway), for some people with triple-negative breast cancer (TNBC).

Datopotamab deruxtecan-dlnk is approved for adults with TNBC that is unresectable, meaning it can’t safely be removed with surgery, or metastatic, meaning it has spread to other parts of the body. It’s for people who aren’t candidates for PD-1/PD-L1 inhibitor therapy, a type of immunotherapy that helps the immune system attack cancer cells.

In the clinical trial that led to approval, people who received datopotamab deruxtecan-dlnk lived longer without their cancer getting worse compared with those who received chemotherapy.

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The new treatment option matters because TNBC can be harder to treat than some other breast cancers. People who can’t receive immunotherapy may have fewer treatment options.

Datopotamab deruxtecan-dlnk is a new first-line option, meaning it can be used before other systemic (whole-body) treatments.

What Is Datroway?

Chemotherapy drug infusion treatment Datopotamab deruxtecan-dlnk is an antibody-drug conjugate. This type of targeted treatment combines an antibody, which can identify cancer cells, with a cancer-killing drug.

Datopotamab deruxtecan-dlnk targets a protein called TROP2, which is found on many cancer cells. Once the drug attaches to TROP2, it enters the cancer cell and delivers chemotherapy directly into it.

Datopotamab deruxtecan-dlnk is the first drug of this kind approved for initial treatment in people with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

The treatment is given as an intravenous (IV) infusion once every three weeks until the cancer gets worse or side effects become too difficult to manage.

What Happened in Clinical Trials?

FDA approval was based on the phase 3 TROPION-Breast02 trial. The study included 644 adults with unresectable or metastatic TNBC who had not yet received chemotherapy or other systemic treatment and who were not candidates for PD-1/PD-L1 inhibitor therapy. Participants received either datopotamab deruxtecan-dlnk or chemotherapy.

Among the trial’s key findings:

Datopotamab deruxtecan-dlnk helped delay cancer growth. People who received the drug had a median progression-free survival of 10.8 months, compared with 5.6 months for people who received chemotherapy.
Datopotamab deruxtecan-dlnk helped people live longer overall. Median overall survival was 23.7 months with datopotamab deruxtecan-dlnk, compared with 18.7 months with chemotherapy.
More people had their tumors shrink or disappear with datopotamab deruxtecan-dlnk. The confirmed overall response rate was 64 percent with datopotamab deruxtecan-dlnk, compared with 30 percent with chemotherapy.

Common and Serious Side Effects

As with any treatment, datopotamab deruxtecan-dlnk comes with the risk of side effects.

The most common side effects reported with datopotamab deruxtecan-dlnk included:

Mouth sores
Nausea
Hair loss
Constipation
Fatigue
Vomiting
Muscle or bone pain
Dry eyes
Inflammation of the cornea (the clear outer layer of the eye)
Anemia and low blood cell counts

The prescribing information includes warnings for:

Interstitial lung disease and pneumonitis (types of lung inflammation)
Eye-related side effects
Mouth sores
Harm to a fetus during pregnancy

What This Means for People With Breast Cancer

Doctor discussing breast cancer treatment options

Datopotamab deruxtecan-dlnk offers a new treatment option for some people with metastatic TNBC who can’t receive PD-1/PD-L1 inhibitor therapy. The approval may help fill an important gap in treatment options by offering another first-line therapy beyond standard chemotherapy.

Not every breast cancer treatment is right for every person. If your current treatment plan isn’t meeting your goals, or if you want to learn what other options may be available, talk with your oncology care team. Your healthcare providers can help you weigh the possible benefits and risks based on your cancer type, treatment history, overall health, and personal goals.