Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer
The Pharma Data
APRIL 27, 2022
The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.
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