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AstraZeneca PLC on Monday said its lung cancer treatment, co-developed with Daiichi Sankyo Co Ltd, is under priority review for approval by the US Food & Drug Administration. The partners, based in Cambridge, England and Tokyo respectively, jointly filed a license application for their cancer therapy, known as datopotamab deruxtecan. The FDA previously designated the drug a ‘breakthrough therapy’. By granting the application ‘priority review’ status, the US regulator has suggested datopotamab deruxtecan could significantly improve current treatment options. Datopotamab deruxtecan is an antibody drug designed to treat non-small cell lung cancer. It focuses on tumours with mutations of the epidermal growth factor receptor gene. These tumours tend to be resistant to other forms of treatment, and usually express a protein called TROP2. According to AstraZeneca and Daiichi Sankyo, theirs would be the first antibody drug conjugate directed at TROP-2 proteins. The two firms are currently running third-phase trials for the treatment. Previous studies recorded an objective response rate of 42.7% over a median duration of seven months. These results were assessed by a blinded independent central review, AstraZeneca said. ‘Treating advanced EGFR-mutated non-small cell lung cancer presents a significant challenge due to the limited efficacy of available treatments once the disease has progressed following front-line therapies,’ said Ken Takeshita, Daiichi Sankyo’s global head of research & development. The FDA’s priority review status recognised ‘the potential for datopotamab deruxtecan to provide a much-needed option to patients whose disease has become resistant to current treatments,’ added Susan Galbraith, AstraZeneca’s executive vice president of oncology research and development. AstraZeneca shares were down 1.0% at 10,876.00 pence each on Monday morning in London. Daiichi Sankyo closed down 1.5% at JP¥4,130 on Friday in Tokyo, which was closed for a holiday on Monday. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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