AstraZeneca: EMA validates Dato-DXd for two cancers


(CercleFinance.com) – AstraZeneca announced Monday that the European Medicines Agency (EMA) had validated its application for marketing authorization as part of the evaluation of Dato-DXd in two types of cancer.

The first decision concerns the treatment of locally advanced or metastatic non-small cell non-squamous cell cancer, requiring systemic therapy after previous treatment.

The other concerns HR positive, but HER2 negative, inoperable or metastatic breast cancer in patients for whom the disease has progressed and who cannot benefit from endocrinotherapy following the administration of a first systemic therapy .

Datopotamab deruxtecan – or Dato-DXd – is an antibody-drug conjugate designed in collaboration with Japan’s Daiichi Sankyo.

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