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More in FDA General
Despite problematic dataset, risk/benefit profile not favorable with PD-L1 expression below 1
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Phase III trial program showed 30% to 34% reduction in moderate or severe exacerbations
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EGFR inhibitor now indicated for unresectable stage III disease following chemoradiotherapy
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Data since approvals suggest benefits limited to subgroups with PD-L1 expression of at least 1%
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Broad indication doubles the number of patients eligible for adjuvant CDK4/6 inhibition
Sep 17, 2024