The Complete Response Letter was issued as a result of inspection findings at a third-party manufacturing facility, unrelated to patritumab deruxtecan’s efficacy or safety in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.
FDA Issues Complete Response Letter to Merck and Daiichi Sankyo for Patritumab Deruxtecan for Advanced, Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
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