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FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-Positive Solid Tumors

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have .

Novel HER3-Directed Therapy Granted Priority Review for Previously Treated NSCLC

The FDA granted priority review of patritumab deruxtecan for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies.

Patritumab Deruxtecan Under Review for Locally Advanced, Metastatic EGFR-Mutated NSCLC

Patritumab deruxtecan is under review to treat previously treated adults with locally advanced or metastatic EGFR-mutated NSCLC.

FDA grants priority review for Daiichi Sankyo-Merck s lung cancer therapy

The US FDA has granted priority review to Daiichi Sankyo and Merck’s BLA for patritumab deruxtecan, to treat non-small cell lung cancer (NSCLC) in adults.

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