ESMO: Pivotal Keytruda Combination Hits And Misses
Merck & Co’s mega-blockbuster checkpoint inhibitor Keytruda hit new clinical highs and lows at ESMO as the major ramps up efforts to expand the drug’s label by exploring novel combinations and cancer settings.
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US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.
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