Posted by Michael Wonder on 29 May 2025
Patritumab deruxtecan biologics license application for patients with previously treated locally advanced or metastatic EGFR mutated non-small cell lung cancer voluntarily withdrawn
29 May 2025 - The biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's patritumab deruxtecan (HER3-DXd) 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EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies has been voluntarily withdrawn.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 biologics license application is based on top line overall survival results from the confirmatory HERTHENA-Lung02 phase 3 trial where overall survival did not meet statistical significance as well as discussions with the US 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.
