Daiichi Sankyo Co Ltd and AstraZeneca PLC on Wednesday said the US Food & Drug Administration has granted priority review for Enhertu in combination with pertuzumab as a first-line treatment for adults with HER2-positive metastatic breast cancer.
The application is supported by data from the phase 3 Destiny-Breast09 trial, which showed the combination reduced the risk of disease progression or death by 44% compared with the current standard of care, taxane plus trastuzumab and pertuzumab.
Median progression-free survival was 40.7 months for patients given Enhertu plus pertuzumab, compared with 26.9 months with the standard therapy.
The FDA has set a target action date of January 23, 2026 under the Prescription Drug User Fee Act. The submission is also being reviewed under the Real-Time Oncology Review programme, which allows regulators to assess parts of applications earlier to accelerate access to new treatments.
Ken Takeshita, global head of R&D at Daiichi Sankyo, said: ‘Receiving priority review moves us closer to offering Enhertu to patients even earlier in the metastatic treatment pathway as a potential new first-line treatment option.’
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said the trial results mark ‘the first major evolution in treatment in this first-line setting in more than a decade.’
Enhertu, a HER2-directed antibody drug conjugate, is already approved in more than 85 countries as a second-line treatment for HER2-positive breast cancer and in additional HER2-driven cancers including gastric and lung cancers.
Shares in AstraZeneca were 0.9% lower at 11,152.00 pence in London on Wednesday morning. Shares in Daiichi Sankyo closed 0.8% lower at JP¥3,415.00 in Tokyo.
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