EMA Grants Trastuzumab Deruxtecan Accelerated Assessment for Advanced HER2-positive Breast Cancer

EMA Grants Trastuzumab Deruxtecan Accelerated Assessment for Advanced HER2-positive Breast Cancer
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 assessment status can significantly reduce bureaucratic review times. Developed in collaboration with AstraZeneca, trastuzumab deruxtecan is an antibody-drug conjugate that specifically targets cancer cells that carry the HER2 protein. It consists of a HER2-specific antibody and the cancer-killing agent deruxtecan, a derivative of exatecan. It is a potential treatment for all types of HER2-positive cancers. “The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing,” said Gilles Gallant, PhD, global head of oncology R&am
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