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AstraZeneca PLC on Tuesday reported mixed news with progress for its cancer treatment Datroway, while US regulatory authorities requested more information on autoimmune disease drug Saphnelo before progressing its application. The Cambridge-based pharmaceuticals company said Datroway has been granted priority review in the US as a 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. The decision was based on results from Tropion-Breast02, showing AstraZeneca and Daiichi Sankyo Co Ltd’s Datroway significantly improved overall survival versus chemotherapy in this patient population. The US Food & Drug Administration grants priority review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the second quarter of 2026. Susan Galbraith, executive vice president, Oncology Haematology R&D, AstraZeneca, said: ‘Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the Tropion-Breast02 trial the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease.’ She said the trial results are even ‘more striking considering the trial enrolled a subset of patients with highly aggressive disease.’ The trial showed Datroway demonstrated a statistically significant and clinically meaningful improvement in median overall survival and a 43% reduction in patients’ risk of disease progression or death compared to chemotherapy as first line treatment. Datroway was also associated with more robust and durable treatment responses. Datroway is a specifically engineered Trop2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. In addition, AstraZeneca said the US Food & Drug Administration issued a complete response letter regarding the biologics license application for Saphnelo for subcutaneous administration in adult patients with systemic lupus erythematosus. The FDA sends complete response letters if it determines that it will not approve the application in its current form. AstraZeneca said it provided the information requested in the letter and is committed to working with the FDA to progress the application as soon as possible. It said a decision from the FDA is expected in the first half of 2026. The firm pointed out intravenous Saphnelo remains commercially available. Shares in AstraZeneca were down 1.2% at 13,878.00 pence each in London on Tuesday morning. Daiichi Sankyo closed up 0.6% at JP¥2,935 in Tokyo. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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