Article Figures & Data
Figures
- Figure 1.
Kaplan–Meier plot of PFS (independent radiology review).
Tables
- Table 1.
Primary efficacy results
Lenvatinib Placebo N = 261 N = 131 PFS (IRR) Median PFS in months (95% CI) 18.3 (15.1–NR) 3.6 (2.2–3.7) HR (95% CI)a 0.21 (0.16–0.28) P valueb <0.001 ORRc ORR (95% CI) 65% (59–71) 2% (0–4) P valuec <0.001 OS Median OS in months (95% CI) NR (22.1–NR) NR (20.3–NR) HR (95% CI)a 0.73 (0.50–1.07) P valuec 0.10 Abbreviations: IRR, independent radiology review; NR, not reached.
↵aCox proportional hazard model stratified by region (Europe vs. North America vs. other), age group (≤65 years vs. >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).
↵bCochran–Mantel–Haenszel χ2 test.
↵cLog-rank test stratified by region (Europe vs. North America vs. other), age group (≤65 years vs. >65 years), and previous VEGF/VEGFR-targeted therapy (0 vs. 1).
December 2015
Volume 21, Issue 23
Volume 21, Issue 23
FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer
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