FDA approves Enhertu for HER2-low breast cancer


The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer.

Enhertu is now the first approved therapy for patients with HER2-low breast cancer subtype.

The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for metastatic cancer or if their cancer returned within 6 months of completing an adjuvant chemotherapy regimen.

Patients with low levels of the HER2 protein have traditionally had fewer treatment options than patients with HER2-positive breast cancer, according to the National Cancer Institute. Treatment options for such patients typically included endocrine therapy or chemotherapy.

Overall, about 2 million women per year are diagnosed with breast cancer.

FDA estimated that approximately 60% of patients with…

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