AstraZeneca: FDA extends approval of Enhertu

(CercleFinance.com) - AstraZeneca announced Friday that the US Food and Drug Administration (FDA) has approved Enhertu, the antibody conjugate it is developing with Japan's Daiichi Sankyo, for the treatment of bronchial cancer.


The biopharmaceutical company said that the FDA's approval is for the treatment of adult patients with inoperable or metastatic non-small cell lung cancer with a HER2 gene mutation.

Specifically, the approval is for patients who have received at least one prior therapy and whose disease specificity has been demonstrated by an FDA approved device.


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