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# Patritumab BLA Pulled by Merck/Daiichi
- URL: https://www.fdaweb.com/patritumab-bla-pulled-by-merck-daiichi/
- Published: 2025-05-29T12:00:00.000Z
- Updated: 2026-09-14T15:13:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159268

Merck/Daiichi Sankyo have withdrawn their BLA for patritumab deruxtecan to treat patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer. A Merck [statement](https://www.merck.com/news/patritumab-deruxtecan-biologics-license-application-for-patients-with-previously-treated-locally-advanced-or-metastatic-egfr-mutated-non-small-cell-lung-cancer-voluntarily-withdrawn/?ref=fdaweb.com) says the decision to pull the BLA was based on topline results from the confirmatory HERTHENA-Lung02 Phase 3 trial in which overall survival did not meet statistical significance. It also followed discussions with FDA, the company says. The statement says the decision was not related to an FDA complete response letter that was issued in 6/2024 and outlined findings about an inspection of a third-party manufacturing facility.

Patritumab deruxtecan is described as a specifically engineered HER3-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi and Merck.