The competition among TROP2-targeting therapies in first-line triple-negative breast cancer (TNBC) has intensified following the U.S. Food and Drug Administration’s approval of Datroway for patients who are not candidates for PD-1/L1 inhibitors.
Daiichi Sankyo and AstraZeneca announced the approval on Friday, noting in May 22 statements that Datroway is currently the only TROP2-directed antibody-drug conjugate (ADC) shown to prolong overall survival compared with chemotherapy in this treatment setting.
The approval was supported by findings from the phase 3 Tropion-Breast02 study. According to the data, Datroway reduced the risk of death by 21% compared with chemotherapy and extended median overall survival by five months to 23.7 months.
The study also showed an improvement in progression-free survival. Datroway reduced the risk of progression by 43%, while Gilead Sciences’ rival TROP2 ADC, Trodelvy, reported a 38% progression-free survival improvement in a separate study. However, the source material noted that cross-trial comparisons can be unreliable because of differences in patient characteristics and study design.
At the 2025 European Society for Medical Oncology Congress in October, results from Gilead’s Ascent-03 study showed that Trodelvy did not achieve statistical significance for overall survival in a comparable first-line TNBC setting involving patients who were not eligible for anti-PD-1/L1 therapies.
Gilead has also reported a positive readout from the Ascent-04 study evaluating Trodelvy in combination with Merck & Co.’s Keytruda in first-line PD-L1-positive TNBC. The company has submitted both indications to the FDA, with a regulatory decision expected in the second half of 2026. Investigators are expected to present data regarding progression on second-line treatment from both studies at the 2026 annual meeting of the American Society of Clinical Oncology.
Seven out of ten patients with metastatic TNBC are not candidates for immunotherapy, according to Arlene Brothers, executive director of the Triple Negative Breast Cancer Foundation. She said, “Today’s approval of Datroway means that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.”
The information provided states that AstraZeneca and Daiichi Sankyo are counting on Datroway’s overall survival results and a halo effect from Enhertu in HER2-positive breast cancer to gain an advantage. Gilead, meanwhile, hopes that positive findings from two trials covering patients regardless of PD-L1 expression, together with physician familiarity with Trodelvy in second-line TNBC, will influence physician preference.
Gilead Chief Commercial Officer Johanna Mercier said during the company’s first-quarter earnings call in early May that the company had already observed some Trodelvy uptake in the first-line setting following its inclusion in treatment guidelines.
Before the FDA approval, both Datroway and Trodelvy had been added to National Comprehensive Cancer Network guidelines with category 1 preferred regimen recommendations for first-line TNBC.
A third TROP2 ADC, sacituzumab tirumotecan (sac-TMT), developed by Kelun-Biotech and partnered with Merck, recently reported positive phase 3 results in China in first-line TNBC. The OpTiTROP-Breast03 study enrolled PD-L1-negative patients as well as PD-L1-positive patients who relapsed after prior anti-PD-1/L1 treatment in early-stage disease. Merck’s global phase 3 TroFuse-011 study is evaluating sac-TMT both as a monotherapy and in combination with Keytruda in PD-L1-negative TNBC. The updated NCCN guideline and Datroway approval could pose some complications for the recruitment of that study in the United States because chemotherapy is being used in the control arm.
Datroway’s application was reviewed under Project Orbis, which supports concurrent regulatory review among international agencies. The treatment is also being reviewed in Australia, Canada, Singapore, Switzerland, the European Union, China, and Japan.
FDA Approves Datroway for First-Line Triple-Negative Breast Cancer in Certain Patients
Datroway has secured FDA approval for the treatment of certain patients with first-line triple-negative breast cancer (TNBC), providing a new therapeutic option for a disease known for its aggressive nature and limited treatment choices. The approval represents a significant milestone for Datroway and highlights ongoing progress in the development of targeted cancer therapies.
Datroway Expands Treatment Options for TNBC
The FDA’s decision allows Datroway to be used in eligible patients with advanced or metastatic triple-negative breast cancer. This approval offers healthcare providers an additional tool for managing a challenging form of breast cancer that often requires innovative treatment approaches to improve patient outcomes.
How Datroway Works
Datroway is designed to target cancer cells more precisely than traditional chemotherapy. By utilizing advanced drug-delivery technology, Datroway aims to attack tumor cells while limiting damage to healthy tissues. This targeted approach has attracted significant attention within the oncology community and contributes to the growing role of precision medicine in cancer treatment.
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