AstraZeneca PLC and its Japanese partner Daiichi-Sankyo Co Ltd have withdrawn an application in the European Union for datopotamab deruxtecan for treating certain forms of non-small cell lung cancer.
Cambridge-based pharmaceuticals firm AstraZeneca said the decision to withdraw the marketing authorisation application was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The application for dato-DXd was for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer. It was based on the Tropion-Lung01 Phase III trial.
AstraZeneca said the two companies will continue to work to bring dato-DXd to patients with lung cancer in the EU.
AstraZeneca and Daiichi Sankyo’s application in the EU for dato-DXd for the treatment of hormone receptor positive, HER2-negative metastatic breast cancer based on the Tropion-Breast01 phase III trial remains under review.
Dato-DXd is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.
Shares in AstraZeneca were 0.5% higher at 10,478.00 pence each in London on Tuesday. Daiichi Sankyo closed up 0.3% at JP¥4,396.00 in Tokyo.
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