Keytruda's Urothelial Cancer Claim Goes From Accelerated To Full Approval, With More Limited Scope
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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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.
Full data presented at ESMO from a closely watched trial of Seagen/Astellas’s Padcev and Merck & Co’s Keytruda should support regulatory approval of the combination in cisplatin-ineligible first-line metastatic urothelial cancer patients but concerns over duration of treatment remain.
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