Press Release

January 18, 2022
1 min read

FDA grants priority review to Enhertu for breast cancer subset


Press Release

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The FDA granted priority review to fam-trastuzumab deruxtecan-nxki for treatment of certain patients with advanced breast cancer.

The designation applies to use of the agent by adults with unresectable or metastatic HER2-positive breast cancer who received a prior anti-HER2-based regimen.

 The main entrance of FDA Building 1.
Source: Adobe Stock.

Fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo, AstraZeneca) is a HER2-directed antibody-drug conjugate.

The FDA based the priority review designation on results of the randomized phase 3 DESTINY-Breast03 trial. Results showed fam-trastuzumab deruxtecan-nxki reduced risk for progression or death by 72% (HR = 0.28; 95% CI, 0.22-0.37) compared with ado-trastuzumab emtansine (Kadcyla, Genentech) among patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab (Herceptin, Genentech) and a taxane.

Researchers reported 1-year OS rates of 94.1% in the fam-trastuzumab deruxtecan-nxki group and 85.9% among those treated with ado-trastuzumab emtansine.

The safety profile of the agent appeared consistent with that observed in prior trials. The most common grade 3 or higher drug-related treatment-emergent adverse events among patients who received fam-trastuzumab deruxtecan-nxki included neutropenia (19.1%), thrombocytopenia (7%), leukopenia (6.6%), nausea (6.6%), anemia (5.8%) and fatigue (5.1%).

An independent adjudication committee determined 10.5% of patients developed interstitial lung disease or pneumonitis related to treatment. Researchers reported two grade 3 cases; all others were grade 1 or grade 2.

The FDA previously granted breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for this indication.

The agent is approved in the United States for treatment of patients with unresectable or metastatic HER2-positive breast cancer who received two or more anti-HER2-based regimens in the metastatic setting. It also is approved for treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who received a prior trastuzumab regimen.