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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Wednesday, July 27, 2022
On July 25, Daiichi Sankyo and AstraZeneca received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the supplemental biologics license application of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the treatment of adults with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization–negative) breast cancer who have received a prior therapy in the metastatic setting. The application has been granted Priority Review. T-DXd is a specifically engineered HER2-directed antibody-drug conjugate being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The application is based on data from the DESTINY-Breast04 phase III trial, presented as a Plenary Session of the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. In this trial, T-DXd demonstrated superior and clinically meaningful efficacy in progression-free survival and overall survival in previously treated patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor (HR-positive or HR-negative) disease versus standard-of-care physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel). The safety profile of T-DXd was consistent with previous clinical trials, with no new safety concerns identified.
DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe, and North America. For more information about the trial, visit ClinicalTrials.gov.
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