KENILWORTH (NJ) (dpa-AFX) - The Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan, co-developed by Merck & Co Inc. (MRK) and Daiichi Sankyo Company, Limited (DSKYF) has been withdrawn, the companies said in a statement on Thursday.
The decision followed topline overall survival (OS) data from the confirmatory HERTHENA-Lung02 phase 3 study, as well as discussions with the U.S. Food and Drug Administration. In the study, OS did not meet statistical significance in EGFR-mutated non-small cell lung cancer (NSCLC) patients.
'While we are disappointed with the overall survival results of HERTHENA-Lung02, we are conducting further biomarker analyses to better identify patients that may benefit from patritumab deruxtecan to guide our continued development in lung cancer,' said Ken Takeshita, Global Head, R&D, Daiichi Sankyo.
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