THE FDA PRESENTATION NDA #21-053

10/12/99


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Table of Contents

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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FDA POINT

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FDA POINT

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SUMMARY

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Author: CDER User