What is it prescribed for?
DATROWAY™ is used to treat adults with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have already received endocrine-based therapy and chemotherapy. Datroway was Approved by the FDA on January 17 2025
What is the name of the drug and what does it do?
The brand name is DATROWAY (pronounced “DAT-roe-way”), and the generic name is datopotamab deruxtecan-dlnk. DATROWAY is intended to treat a specific type of advanced breast cancer that cannot be removed by surgery or has spread to other parts of the body.
How does it work?
DATROWAY is a targeted therapy that binds to a protein called Trop-2 found on cancer cells. After binding, the drug releases a chemotherapy agent directly inside the cancer cells, causing DNA damage that leads to cell death.
What did the research discover?
In the TROPION-Breast01 clinical research study:
- Patients treated with DATROWAY lived longer without their cancer getting worse compared to those treated with regular chemotherapy.
- The median progression-free survival was 6.9 months with DATROWAY versus 4.9 months with chemotherapy.
- About 36% of patients treated with DATROWAY experienced significant tumor shrinkage, compared to 23% with chemotherapy.
- However, overall survival between the DATROWAY and chemotherapy groups was similar.
What are some of the side effects?
Common side effects (occurred in 20% or more of patients):
- Mouth sores (stomatitis)
- Nausea
- Fatigue
- Low white blood cell counts
- Low calcium levels
- Hair loss (alopecia)
- Low lymphocytes
- Low hemoglobin
- Constipation
- Low neutrophils
- Dry eye
- Vomiting
- Increased liver enzymes (ALT, AST)
- Eye inflammation (keratitis)
What are the dosage recommendations and how is it prescribed?
DATROWAY is given by intravenous infusion:
- The recommended dose is 6 mg/kg once every 3 weeks.
- Patients must receive premedication to prevent infusion reactions and nausea.
- Eye exams are required before starting and during treatment, and patients must use preservative-free eye drops regularly.
- Mouthwash containing a steroid is also recommended to prevent mouth sores.
Source:
Daiichi Sankyo, Inc. DATROWAY (datopotamab deruxtecan-dlnk) for injection. Prescribing Information. 2025. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf
