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EMA validates Dato-DXd MAAs for NSQ NSCLC and BC
EMA validates Dato-DXd MAAs for NSQ NSCLC and BC.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n \n4 March 2024\n \nTwo datopotamab deruxtecan applications validated in the EU for\npatients with advanced nonsquamous non-small cell lung\ncancer or HR-positive, HER2-negative breast cancer\n \nParallel applications based on TROPION-Lung01 and TROPION-Breast01 Phase III trial results demonstrating AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan significantly improved progression-free survival vs. chemotherapy in two types of cancer\n \nThe European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) in two types of cancer. One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment. The other MAA is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy.\n \nThe validations confirm the completion of the applications and commence the scientific review process by the EMA's Committee for Medicinal Products for Human Use. The applications are based on data from the pivotal TROPION-Lung01 and TROPION-Breast01 Phase III trials presented during two Presidential Symposia at the 2023 European Society for Medical Oncology Congress.\n \nDatopotamab 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.\n \nSusan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: \"Our ambition is for datopotamab deruxtecan to improve upon and replace conventional chemotherapy in the treatment of multiple cancer types. Today's dual validation of our applications in lung and breast cancers brings this potential medicine a meaningful step closer to redefining treatment expectations for patients with two of the most common cancers in Europe.\"\n \nKen Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: \"The EMA validation is an important first step toward bringing this TROP2-directed antibody drug conjugate t...