Presentation on theme: "U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only."— Presentation transcript:
U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
Past FDA Approvals in Colorectal Cancer Amna Ibrahim M.D DODP, FDA
Outline of Presentation Drugs approved for colon cancer (adjuvant, first-line and second-line therapy) Studies supporting drug approval Drugs discussed at ODAC without subsequent drug approval Endpoints supporting approval
Irinotecan (Recurrent) (full reg. approval) StudyArmsNOS (mo.) p 1CPT 111899.20.0001 Best Supportive Care 906.5 2CPT 1112710.80.035 5FU-based regimens 1298.5
Oxaliplatin (Recurrent) (accelerated approval) StudyArmsNRR (%) TTP (mo. with 95% CI) P for RR 1Oxaliplatin + 5FU/LV (FOLFOX4) 15294.6 (4.2 – 6.1) 0.0002 5FU + LV15102.7 (1.8-3.0) Oxaliplatin15611.6 (1.4-2.7)
NDAs Discussed at ODAC but not Approved Issues at ODAC UFT - contribution of uracil to UFT -analysis and interpretation of non-inferiority Oxaliplatin (2000) -trials designed for RR & PFS did not demonstrate OS improvement
Basis of Approval Adjuvant Therapy (1 full approval) Superiority in Survival (1) First-line Therapy (3 full approvals) Superiority in Survival (2) Non-inferiority in Survival (1) Therapy for Recurrent Disease (2 AA; 1 full approval) Survival (1 full for CPT-11) RR and/or TTP (1 AA for oxal, 1 for CPT-11)