Priority Review Granted by FDA to Trastuzumab Deruxtecan in HER2-Positive Breast Cancer

By: JNCCN 360 Staff
Posted: Friday, January 21, 2022

On January 17, AstraZeneca and Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for the treatment of adults in the United States who have unresectable or metastatic HER2-positive breast cancer and have received prior anti-HER2–based therapy. The FDA also accepted their supplemental biologics license application of T-DXd for this patient population.

T-DXd is a HER2-directed antibody-drug conjugate being jointly developed by the two companies. It has been approved in the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens, based on the results of the DESTINY-Breast01 trial.

The current application is based on results from the phase III global DESTINY-Breast03 trial, which has enrolled about 500 patients at multiple sites in North America, Asia, Europe, Oceania, and South America. According to the data from this trial, nearly all patients treated with T-DXd were alive at 1 year (94.1%), compared with 85.9% of patients treated with T-DM1 (ado-trastuzumab emtansine). The confirmed objective response rate was more than doubled in the T-DXd arm versus the T-DM1 arm (79.7% vs. 34.2%). The toxicity profile of T-DXd was reported to be consistent with previous clinical trials, with no new safety concerns identified and no grade 4 or 5 treatment-related interstitial lung disease events.

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