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This includes comprehensive toxicological evaluation, such as subchronic and chronic toxicity studies, genotoxicity testing (e.g., Ames and micronucleus assays), reproductive toxicity studies, and drugdrug interaction assessments, particularly for compounds affecting CYP450 pathways

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This followed a March approval for Rybrevant in combination with chemo for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations