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AstraZeneca, Daiichi Sankyo’s Enhertu Approved in Solid Tumors

Becomes first tumor-agnostic approval of a HER2-directed therapy and ADC by the FDA.

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By: Kristin Brooks

Managing Editor, Contract Pharma

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the U.S. FDA for the treatment of adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.   This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verific...

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