AstraZeneca and Daiichi secure US fast-track status for cancer drug

(Alliance News) - AstraZeneca PLC and Daiichi Sanyko Co Ltd on Monday reported that their co-developed breast cancer treatment Enhertu had secure priority review status in the US.

Enhertu, or famtrastuzumab deruxtecan-nxki, is an HER2 directed DXd antibody drug conjugate. It was discovered by Tokyo-based Daiichi, but is being co-developed and commercialised with Cambridge, England-based AstraZenenca.

The US Food & Drug Administration has accepted a supplemental biologics license application for Enhertu, and set the treatment on track for accelerated approval, having previously recognised it as a "breakthrough therapy" back in December.

This decision was based on positive third-phase trial data, noted Daiichi, and relates specifically to the treatment of adults with HER2 positive breast cancer, who exhibit residual invasive symptoms after pre-surgical treatment.

Daichii added that Enhertu "is being reviewed under Project Orbis, which provides a framework for the concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible."

Ken Takeshita, Daichii's global head of Research & Development, said: "For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease."

Susan Galbraith, executive vice president of Oncology Hematology R&D at AstraZeneca commented: "With this priority review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure."

AstraZeneca shares closed 1.0% lower at 14,628.00 pence on Friday in London. Daichii closed down 0.6% at JPY2,849.00 on Monday in Tokyo.

By Holly Munks, Alliance News reporter

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