FDA Approves Dato-DXd for Breast Cancer

On Jan. 17, 2025, the U.S. Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (brand name: Datroway), commonly called Dato-DXd by doctors, to treat adults diagnosed with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer that grew during previous treatment with hormonal therapy and chemotherapy.

Unresectable means the cancer can’t be removed with surgery. 

The FDA approval was based on results from the TROPION-Breast01 trial. That study found that people who received Dato-DXd had better progression-free survival — which is how long a person lives without the cancer growing — than people who received standard chemotherapy.

See the Dato-DXd prescribing information.

Dato-DXd is a type of targeted therapy called an antibody-drug conjugate (ADC). ADCs target specific proteins found on and in cancer cells. Once the medicine attaches to these proteins it releases the chemotherapy, which can destroy the cancer cell.

Dato-DXd is made up of two main parts: 

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  a monoclonal antibody called datopotamab that targets the Trop-2 protein 

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  a chemotherapy medicine called DXd

The datopotamab part of Dato-DXd helps track down cancer cells, which have higher amounts of the Trop-2 protein on their surface than other cells. The antibody then attaches to the Trop-2 protein. Once inside the cell, the DXd chemotherapy is released. 

The DXd chemotherapy isn’t a targeted medicine like datopotamab is, so it can affect healthy cells as well as cancer cells. But because the DXd is linked to the datopotamab, the medicine is able to target cancer cells with Trop-2 proteins on them. This makes Dato-DXd less toxic to healthy cells and more effective in treating cancer cells.

Dato-DXd is given intravenously as an infusion, which means the medicine is delivered directly into your bloodstream through an IV or port. Dato-DXd usually is given in doses of 6 mg/kg every three weeks until the cancer grows or you develop unacceptable side effects.

The first infusion of Dato-DXd takes about 90 minutes. Infusions after that take about 30 minutes.

Like most breast cancer medicines, Dato-DXd can cause side effects, sometimes severe. The most common side effects of Dato-DX seen in the TROPION-Breast01 study were:

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  nausea

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  mouth sores

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  vomiting

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  dry eye

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  fatigue

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  hair loss

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  constipation

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  liver problems

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  low white blood cell counts

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  anemia

More rarely, Dato-DXd also may cause serious side effects, including:

Interstitial lung disease: Interstitial lung disease is a general term for disorders that cause inflammation and scarring in the lungs. The scarring makes lung tissue stiff, which makes it difficult to breathe. You should be closely monitored for signs of interstitial lung disease while receiving Dato-DXd. Tell your doctor right away if you experience shortness of breath or have a dry cough.

Severe eye problems: Besides dry eye, Dato-DXd also may cause ulcers on the cornea (the outer layer of the eye that allows light to enter), as well as blurred vision and pink eye (conjunctivitis). Your doctor will likely recommend you avoid wearing contact lenses and use preservative-free lubricating eye drops while you’re receiving Dato-DXd. You also should have a complete eye exam (including checks of your eye pressure, retina, and optic nerve) when you start Dato-DXd, every year while you’re receiving it, and again at the end of treatment.

Severe mouth sores: To help prevent painful mouth sores and infection, your doctor will probably recommend you use a mouthwash that contains a steroid while you’re receiving Dato-DXd. It’s also recommended that you hold ice chips or ice water in your mouth while you’re receiving a Dato-DXd infusion.

You should not receive Dato-DXd if you’re pregnant or planning to get pregnant. Dato-DXd can cause embryo death and birth defects. If you’re able to get pregnant, it’s important to use effective birth control while you’re receiving Dato-DXd and for seven months after your last dose. People receiving Dato-DXd with partners who can become pregnant should use effective birth control while receiving Dato-DXd and for four months after the last dose.

The cost of Dato-DXd may vary. The price you’ll pay depends on your health insurance provider and plan, where you live, and the pharmacy you use. 

Note: Your insurance company may require you to get prior authorization before covering Dato-DXd.

If your doctor prescribes Dato-DXd and you have problems getting it covered by insurance or don’t have insurance, both Daiichi-Sankyo and AstraZeneca, the companies that make Dato-DXd, have patient assistance programs. 

Learn more about financial assistance and medicine cost-lowering tips.