Enhertu (famtrastuzumab deruxtecan-nxki) is granted priority review in the U.S. for patients with metastatic HER2 positive solid tumors
Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application (sBLA) for Enhertu (famtrastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options
Enhertu is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.
The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is May 30, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in August 2023 for Enhertu in metastatic HER2 positive solid tumors.
The sBLA is based on data from the ongoing DESTINY-PanTumor02 phase II trial where Enhertu demonstrated clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2 expressing advanced solid tumors. Data from other supporting 2 trials in patients with HER2 positive IHC 3+ tumors in the ENHERTU clinical development program, including DESTINY-Lung01 and DESTINY-CRC02, also were included in the submission.
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