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FDA Grants Priority Review of AZ/Daiichi Sankyo’s Enhertu®

Jan 29, 2024

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

On 18 October 2023, the European Commission approved Enhertu® to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.