Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Tuesday that they have voluntarily withdrawn their marketing authorisation application (MAA) for datopotamab deruxtecan in the European Union for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
This decision follows feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Daiichi Sankyo and AstraZeneca will continue to investigate the potential of datopotamab deruxtecan in other lung cancer settings through an ongoing clinical development programme.
Datopotamab deruxtecan is an antibody-drug conjugate (ADC) being jointly developed by the two companies.
The EU application for datopotamab deruxtecan in hormone receptor-positive, HER2-negative metastatic breast cancer remains under review.
The TROPION-Lung01 trial, a global phase 3 study, evaluated the efficacy and safety of datopotamab deruxtecan compared to docetaxel in patients with NSCLC.
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