Datroway (datopotamab deruxtecan-dlnk) is a prescription intravenous targeted cancer medicine called an antibody-drug conjugate (ADC). The FDA has approved it for adults with triple-negative breast cancer (TNBC) when the tumor cannot be removed with surgery (unresectable) or has spread (metastatic) and the patients are not eligible for immunotherapy targeting PD-1/PD-L1 proteins.
TNBC makes up about 15% of all breast cancer cases worldwide, with around 345,000 new cases diagnosed each year. It is more common in younger women, especially among Black and Hispanic women. Unlike other types of breast cancers, TNBC does not have estrogen, progesterone, or overexpressed HER2 receptors, making it more aggressive and harder to treat with standard hormone or targeted therapies. Patients with advanced or metastatic TNBC often survive only 12-18 months after diagnosis. Until recently, chemotherapy was the only first-line treatment option for TNBC, and although combining immunotherapy with chemotherapy can benefit some patients, about 70% of patients with TNBC are not eligible for immunotherapy.
Datroway is an ADC designed to attack cancer cells while causing minimal harm to healthy cells. The combination contains deruxtecan, a chemotherapy agent, and the lab-made monoclonal antibody datopotamab, which selectively targets TROP2 (a protein commonly found in many solid tumors, including TNBC). Once the antibody attaches to cancer cells, it releases deruxtecan directly inside, where it damages the cells’ DNA and stops them from growing.
This approval matters because it provides a better first-line treatment option than standard chemotherapy for patients with advanced TNBC, especially those who cannot receive immunotherapy.
The FDA reviewed Datroway under the Priority Review pathway, which is reserved for medicines that could offer significant improvements in treating serious diseases.
The FDA’s decision was based on data from a clinical study that included 644 patients with unresectable or metastatic TNBC who had not received prior chemotherapy or systemic anticancer treatment and were not eligible for PD-1/PD-L1 immunotherapy. Patients received either Datroway via intravenous infusion every three weeks or the physician’s choice of single-agent chemotherapy.
The results showed that compared with single-agent chemotherapy, Datroway extended the time before the cancer worsened, improved overall survival, and increased tumor shrinkage rates. Median numbers favored Datroway, with patients living longer without their cancer getting worse (10.8 vs 5.6 months) and showing higher overall survival (23.7 vs 18.7 months) and confirmed overall response rate (64% vs 30%).
The safety profile of Datroway in this study was similar to what had been observed in earlier breast cancer trials with the same medicine. The common side effects included mouth sores (stomatitis); higher amylase levels; nausea; vomiting; hair loss; decreased red and white blood cell counts; low hemoglobin, calcium, and sodium levels; tiredness; dry eye, irritation, blurred vision, inflammation of the cornea (keratitis); and muscle or joint pain.
Datroway may cause serious and life-threatening conditions such as severe interstitial lung disease (ILD) and pneumonitis.
Datroway is given by intravenous infusion once every three weeks (21-day cycle). Treatment continues until your cancer grows again or side effects require stopping it.
Before starting and during treatment with Datroway, your health care provider will check your eyes and may advise you to use preservative-free lubricating eye drops during the course of your therapy. Avoid using contact lenses while receiving Datroway.
Your health care team may suggest supportive steps, such as using a steroid mouthwash to lower the chance of mouth sores and holding ice chips or ice water in your mouth during infusion.
Be sure to tell your health care provider about your medical history and all the medications, vitamins, and herbal supplements you take.
Datroway can harm a fetus. Use effective birth control during treatment and for seven months after your final dose if you are female and for four months after your final dose if you are male. Do not breastfeed during treatment and for one month after your final dose.
Datroway may affect your ability to have children. If this is important to you, you may want to talk with your health care provider about options before starting treatment.
Call your health care provider right away if you notice a new or worse cough, shortness of breath, a fever, or other new or worsening breathing symptoms. Your health care team may pause treatment and start steroids. If severe ILD or pneumonitis is confirmed, your health care provider will stop treatment. Report any changes in vision, eye pain, light sensitivity, or grittiness. Your dose or schedule may change based on your symptoms.