AstraZeneca: FDA extends Enhertu approval


AstraZeneca announced Friday that the US FDA had approved Enhertu, the antibody-conjugate it developed with Japanese Daiichi Sankyo, in the treatment of lung cancer.

The biopharmaceutical group specifies that the approval of the health authority relates to the treatment of adult patients suffering from inoperable or metastatic non-small cell lung cancer accompanied by a mutation of the HER2 gene.

Its green light more specifically concerns patients who have already received at least one treatment, and whose specific pathology has been confirmed by an FDA-approved device.

This decision by the American agency, which follows an accelerated review procedure, will trigger the payment of a milestone payment of 125 million dollars from AstraZeneca Daiichi Sankyo, its partner in the context of the development and marketing of Enhertu.

This antibody was already authorized in the United States for the treatment of certain breast and gastric cancers expressing mutations in the HER2 gene.

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