LONDON (dpa-AFX) - British drug maker AstraZeneca Plc (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK) said that they have voluntarily withdrawn their marketing authorisation application (MAA) in the European Union for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). This decision was based on feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Despite the withdrawal, the companies said they remain committed to making datopotamab deruxtecan available to lung cancer patients in the EU who could benefit from it. They are determined to unlock the potential of this medicine through their extensive clinical development programme, which includes seven pivotal trials across various lung cancer settings.
AstraZeneca and Daiichi Sankyo's application in the EU for datopotamab deruxtecan for the treatment of hormone receptor (HR)-positive, HER2-negative metastatic breast cancer based on the TROPION-Breast01 Phase III trial remains under review.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo.
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