The drug was approved for people who are not eligible for immunotherapy.
Key Takeaways
- Datroway (Dato-DXd, or datopotamab deruxtecan) is the first TROP-2 directed antibody-drug conjugate FDA approved for women with metastatic or unresectable triple-negative breast cancer.
- Specifically, patients who are ineligible for immunotherapy may be candidates for Datroway, giving them a new treatment option.
- Datroway delivers targeted treatment to cancer cells and can be given as a first-line treatment in this population.
The U.S. Food and Drug Administration (FDA) recently approved Datroway(Dato-DXd, or datopotamab deruxtecan) as a first-line therapy for some women with triple-negative breast cancer (TNBC). First-line approval—meaning this is the best first treatment—is significant since patients with aggressive metastatic TNBC have limited treatment options.
With this approval, Datroway is now an option for women with metastatic or unresectable (meaning it cannot be removed by surgery) TNBC who are not eligible for immunotherapy. This provides a new avenue of treatment for this often difficult to treat type of breast cancer.
The approval comes after the impressive results from the TROPION-Breast02 trial, which showed improved survival outcomes for patients taking Datroway compared to those on chemotherapy. BCRF researcher Dr. Tiffany Traina was involved in the study.
Like the recently approved Enhertu for metastatic breast cancer, Datroway is an antibody-drug conjugate that acts like a “smart chemotherapy” against the cancer. It combines an antibody that targets the TROP2 protein found on cancer cells with a powerful chemotherapy. It was previously approved for unresectable or metastatic hormone receptor (HR)-positive/HER2-negative breast cancer as well as for some patients with lung cancer.
The new approval marks a turning point for treating TNBC, Dr. Traina says.
“This is one of the most aggressive and difficult-to-treat forms of breast cancer, and for far too long, our options for patients who are not candidates for immunotherapy have been limited,” she says. “The TROPION-Breast02 trial showed that patients treated with datopotamab deruxtecan lived longer and did so while maintaining their quality of life. That balance matters enormously. For patients with advanced triple-negative breast cancer, this approval is real, meaningful hope.”
Progression-free survival (the time before the cancer returns or gets worse) nearly doubled for patients on Datroway compared to chemotherapy (10.8 vs. 5.6 months). That signals a 43% reduction in the risk of disease progression or death. Overall survival also improved, from 18.7 months to 23.7 months.
And, 64% of patients taking Datroway also saw their tumors shrink or disappear, compared to 30% on chemotherapy.
Triple-negative breast cancer makes up 10% to 15% of all breast cancers. It is an aggressive form of the disease and disproportionally affects younger women, particularly younger Black and Hispanic women. It is the most commonly diagnosed cancer in women with inherited mutations in the BRCA1 gene, and tends to be more advanced when diagnosed.
This is an exciting advancement in breast cancer treatment, particularly for aggressive forms. Donate to BCRF today to help fuel research to find a cure.
