The biologics license application seeking accelerated approval in the U.S. for Daiichi Sankyo and Merck’s (MRK), known as MSD outside of the United States and Canada, patritumab deruxtecan based on the HERTHENA-Lung01 phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies has been voluntarily withdrawn. The decision to withdraw the BLA is based on topline overall survival results from the confirmatory HERTHENA-Lung02 phase 3 trial where OS did not meet statistical significance as well as discussions with the FDA. The decision is unrelated to the complete response letter that was received in June 2024 and outlined findings pertaining to an inspection of a third-party manufacturing facility. Patritumab deruxtecan is a specifically engineered HER3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
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