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THE FDA PRESENTATION NDA #21-053
THE FDA REVIEW TEAM
PROPOSED INDICATION
THE PIVOTAL TRIALS
STUDY –11 Multicenter Phase III Study of 5-FU or UFT in Combination with Leucovorin in Patients with Previously Untreated Metastatic Colorectal Carcinoma PRIMARY ENDPOINT: SURVIVAL 816 PATIENTS US, CANADA, EUROPE, ISRAEL
STUDY –12
ORAL UFT + LV VS. INTRAVENOUS 5-FU + LV
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FDA POINT
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SUMMARY
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Author: CDER User
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