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FDA approval: No clear standalone approval identified for the exact doublet as a separately approved regimen.
EMA approval: No separate named approval for the exact doublet, but not required if covered under trastuzumab label language. Herceptin EPAR states trastuzumab is indicated in combination with an aromatase inhibitor for postmenopausal patients with HR-positive metastatic HER2-positive breast cancer not previously treated with trastuzumab.
see also:
Aromatase inhibitors + ErbB2 / HER-2 / HER2/neu receptor antagonists & Breast cancer / Mammacarcinoma (HR+) (HER2+)
[Breast cancer / Mammacarcinoma (HR+) (HER…