The European Medicines Agency (EMA) has validated Daiichi Sanyoko‘s marketing authorization application for trastuzumab deruxtecan (DS-8201) for the treatment of inoperable or metastatic HER2-positive breast cancer, the company announced. The validation means that the application is complete and may now begin the scientific review process by the Committee for Medicinal Products for Human Use. The committee also granted trastuzumab deruxtecan accelerated assessment, as a therapeutic innovation expected to be of major public health interest. Accelerated…
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