The European Medicines Agency confirmed on December 18, 2025 that the Type II Variation marketing authorization application for DATROWAY (datopotamab deruxtecan) has been validated, opening the path to a first‑line indication for adult patients with unresectable or metastatic triple‑negative breast cancer (TNBC) who are not eligible for PD‑1/PD‑L1 inhibitor therapy.
DATROWAY is a TROP2‑directed antibody‑drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca. The approval is based on the TROPION‑Breast02 Phase III trial, which showed a median overall survival of 23.7 months versus 18.7 months for chemotherapy, and a median progression‑free survival of 10.8 months versus 5.6 months. These results represent a statistically significant improvement over standard chemotherapy and provide a strong clinical foundation for the new indication.
The global TNBC market was valued at approximately USD 4.2 billion in 2023 and is projected to grow to USD 7.1 billion by 2034, a CAGR of about 4.7 %. Current first‑line treatment for metastatic TNBC in patients who cannot receive immunotherapy is largely conventional chemotherapy, which offers limited efficacy and significant toxicity. DATROWAY’s demonstrated survival benefit positions it as a potential new standard of care and could capture a meaningful share of this expanding market.
AstraZeneca’s Q3 2025 results showed revenue of USD 4.3 billion, up 21 % year‑over‑year, driven by strong performance in its oncology portfolio. The company reiterated its full‑year 2025 guidance, maintaining revenue expectations of USD 4.3 billion and core earnings per share of USD 1.64. The EMA validation reinforces the company’s strategy to accelerate its ADC platform and supports its ambition to reach USD 80 billion in total revenue by 2030.
Management highlighted the significance of the EMA validation. CEO Pascal Soriot said the approval “is a meaningful step toward bringing an alternative to traditional chemotherapy for the first time in Europe.” Executive Vice President Susan Galbraith added that the validation “underscores the clinical value of DATROWAY and strengthens our oncology pipeline.” The approval is expected to accelerate market entry, enhance AstraZeneca’s competitive positioning against other ADCs such as sacituzumab govitecan, and contribute to the company’s long‑term growth objectives.
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