Posted by Michael Wonder on 27 Jun 2024
Patritumab deruxtecan BLA submission receives complete response letter from FDA due to inspection findings at third-party manufacturer
27 June 2024 - The letter did not identify any issues with the efficacy or safety data submitted in the application.
The US FDA has issued a complete response letter for the biologics license application seeking accelerated approval of Daiichi Sankyo and Merck/MSD patritumab deruxtecan 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.
