(Sharecast News) - Drugmaker AstraZeneca said on Monday that its breast cancer therapy Datroway has been recommended for approval in the EU as a first‑line monotherapy for adults with unresectable or metastatic triple‑negative breast cancer who are not eligible for PD‑1/PD‑L1 inhibitor treatment.
AstraZeneca said the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use was based on results from its Phase III TROPION‑Breast02 trial.

In the study, Datroway delivered a statistically significant and clinically meaningful improvement in both overall survival and progression‑free survival versus chemotherapy. Median overall survival was 23.7 months for Datroway compared with 18.7 months for chemotherapy, representing a five‑month gain. The treatment also reduced the risk of disease progression or death by 43%.

Datroway, developed jointly with Daiichi Sankyo, produced stronger response rates as well, with an objective response rate of 62.5% versus 29.3% for chemotherapy. If approved, Datroway would become the first TROP2‑directed antibody‑drug conjugate in the EU to show an overall‑survival benefit in the first‑line TNBC setting.

Datroway was cleared in the US in May 2026 for the same indication, and regulatory reviews are ongoing in China, Japan, Australia, Canada, Singapore and Switzerland under Project Orbis. The therapy is a specifically engineered TROP2‑directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca.

Susan Galbraith, executive vice president of AstraZeneca's oncology haematology R&D unit, said: "As one of the hardest cancers to treat, today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years. This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU."

AstraZeneca also said the pair's Enhertu candidate has secured European Union approval as the first tumour‑agnostic HER2‑directed therapy and antibody‑drug conjugate for adults with previously treated HER2‑positive metastatic solid tumours, following positive opinions from the EMA's Committee for Medicinal Products for Human Use.

The decision was supported by data from three Phase II studies, which delivered objective response rates of 52.3%, 52.9% and 46.9%, respectively. AstraZeneca said the approval triggers a $25m milestone payment to partner Daiichi Sankyo. Enhertu, jointly developed by AstraZeneca and Daiichi Sankyo, becomes the first HER2‑targeted therapy in the EU to receive a tumour‑agnostic indication.

As of 0815 BST, AstraZeneca shares were up 0.25% at 14,354p.









Reporting by Iain Gilbert at Sharecast.com

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