19th Jan 2026 09:42
(Alliance News) - Daiichi Sanyko Co Ltd on Monday said EU regulators had validated an application for its breast cancer treatment, Enhertu with pertuzumab, jointly developed with AstraZeneca PLC.
This clears the way for a scientific review by the European Medicines Agency, Daiichi noted.
The Tokyo-based pharmaceutical firm has applied for Enhertu, or trastuzumab deruxtecan, plus pertuzumab to be a first-line treatment for adults with HER2 positive metastatic breast cancer.
Daiichi claims discovery of the antibody drug conjugate, which it is commercialising in partnership with Cambridge, England-based AstraZeneca.
Validation from the EU regulator was based on results of a phase-three study, which linked the drug to "significantly improved progression-free survival versus current first-line standard of care," Daiichi added.
"This validation in the EU is an important step in moving us closer to offering Enhertu in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer," said Ken Takeshita, managing director and global head of R&D at Daiichi.
"Following the recent approval in the US for this indication, we look forward to working closely with the EMA to bring Enhertu to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade."
Daiichi shares closed 1.2% lower at JPY3,270.00 on Monday in Tokyo. AstraZeneca was down 0.6% at 13,972.00 pence on Monday morning in London.
By Holly Munks, Alliance News reporter
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