As reported on Stock Titan, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Datroway® (datopotamab deruxtecan) as a first-line monotherapy for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 inhibitor therapy.
The recommendation is supported by data from the phase 3 TROPION-Breast02 trial and now moves to the European Commission, which will make the final decision on EU marketing authorization.
Developed jointly by Daiichi Sankyo and AstraZeneca, Datroway is a TROP2-targeting antibody-drug conjugate (ADC) designed to deliver a potent cytotoxic payload directly to cancer cells expressing the TROP2 protein. If approved, it could become the first TROP2-directed ADC in the European Union to demonstrate an overall survival advantage as an initial treatment for this patient population.
Phase 3 Trial Demonstrated Survival Benefit
Results from the TROPION-Breast02 study showed that Datroway outperformed physician-selected chemotherapy across key efficacy measures in patients with metastatic TNBC who were not candidates for immunotherapy.
Patients receiving Datroway achieved a median overall survival of 23.7 months, compared with 18.7 months for those treated with standard chemotherapy, representing a five-month improvement. The therapy also significantly reduced the risk of death.
Progression-free survival findings were similarly favorable. Median progression-free survival reached 10.8 months with Datroway versus 5.6 months with chemotherapy, translating to a 43% reduction in the risk of disease progression or death.
Tumor response rates further highlighted the drug’s activity. More than 62% of patients treated with Datroway experienced an objective response, compared with approximately 29% of patients receiving chemotherapy.
Addressing an Area of Unmet Need
Metastatic triple-negative breast cancer remains one of the most challenging breast cancer subtypes to manage. Patients who cannot receive immune checkpoint inhibitors have traditionally relied on chemotherapy, which is often associated with limited durability of response and significant toxicity.
Company representatives described the CHMP recommendation as a potential milestone that could expand treatment options and potentially shift first-line care away from traditional chemotherapy in eligible patients.
Safety Profile
The safety analysis included 319 patients with TNBC treated with Datroway at a dose of 6 mg/kg. Frequently reported adverse events included:
- Stomatitis
- Nausea
- Alopecia
- Fatigue
- Constipation
- Dry eye and keratitis
- Anemia and other hematologic abnormalities
- Elevated liver enzymes
- Musculoskeletal pain
- Vomiting
Serious adverse events occurred in 17% of treated patients. The most commonly reported serious events included pneumonia, vomiting, COVID-19, and anemia. One treatment-related death due to interstitial lung disease/pneumonitis was reported.
Regulatory Outlook
Datroway received U.S. approval in May 2026 for adults with unresectable or metastatic TNBC who are not eligible for PD-1/PD-L1 inhibitor therapy. Regulatory reviews are also ongoing in several other regions, including China, Japan, Australia, Canada, Singapore, and Switzerland, with some applications proceeding through the international Project Orbis framework.
A final European Commission decision is expected following review of the CHMP recommendation. If authorized, Datroway could introduce a new first-line treatment option for patients with metastatic TNBC who have limited alternatives beyond conventional chemotherapy.
