Conditional Approval Urged in EU for Trastuzumab Deruxtecan

Conditional Approval Urged in EU for Trastuzumab Deruxtecan

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Conditional Approval Urged in EU for Trastuzumab Deruxtecan

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the conditional approval of trastuzumab deruxtecan (DS-8201) for the treatment of patients with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. The therapy, which has received accelerated assessment in Europe, already has been approved in Japan and in the U.S., under the trade name Enhertu. The U.S. approval was granted after trastuzumab deruxtecan was granted priority…

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