FDA declines approval of Merck & Daiichi Sankyo's lung cancer treatment due to third-party manufacturing issues.
The US FDA declined to approve Merck & Co and Daiichi Sankyo's lung cancer treatment, patritumab deruxtecan (HER3-DXd), due to findings from an inspection of a third-party manufacturing facility. The FDA's complete response letter did not identify any issues with the efficacy or safety data submitted. Merck and Daiichi Sankyo plan to work with the FDA and the third-party manufacturer to address the feedback and bring the treatment to market.
June 27, 2024
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