AstraZeneca PLC and Daiichi Sankyo Co Ltd on Tuesday said their cancer drug Enhertu received a priority review by the Food & Drug Administration in the US for some forms of breast cancer.

The Cambridge, England-based pharmaceutical company and its Tokyo-based peer said the priority review was for treating adults with forms of unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting.

The priority review is based on positive phase 3 trial results which compared Enhertu to chemotherapy.

The companies expect a regulatory decision by the FDA in the first quarter of 2025.

Susan Galbraith, executive vice president, Oncology research & development at AstraZeneca, said: ‘While endocrine therapies are widely used in the initial treatment of HR-positive metastatic breast cancer, most patients see limited benefit with additional lines of treatment, and subsequent chemotherapy is associated with poor response rates and outcomes. The results from DESTINY-Breast06 show that Enhertu has the potential to evolve the current HR-positive treatment landscape and become the first targeted treatment for patients with HER2-low or HER2-ultralow expression following endocrine therapy.’

Ken Takeshita, global head, R&D at Daiichi Sankyo, said: ‘This priority review highlights the potential to expand the existing indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. We look forward to working closely with the FDA with the goal of bringing Enhertu to more patients as quickly as possible.’

AstraZeneca shares rose 0.4% to 11,630.88 pence each on Tuesday morning in London, while Daiichi shares closed 0.1% higher at JP¥4,715.00 in Tokyo.

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