FDA expands Enhertu approval for breast cancer

The FDA expanded the approval of fam-trastuzumab deruxtecan to include treatment of patients with HER2-positive metastatic breast cancer who received a prior anti-HER2-based regimen.
Fam-trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 inhibitor payload; and a tetrapeptide-based cleavable linker.
The agent already had been approved in the United States for treatment of adults

The FDA expanded the approval of fam-trastuzumab deruxtecan to include treatment of patients with HER2-positive metastatic breast cancer who received a prior anti-HER2-based regimen.
Fam-trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 inhibitor payload; and a tetrapeptide-based cleavable linker.
The agent already had been approved in the United States for treatment of adults