IMPORTANT SAFETY INFORMATION

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction. An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent discontinuation of Nexavar. continue reading below »

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Increased overall survival

In the SHARP* Trial, Nexavar demonstrated a significant overall survival advantage

44% increase in overall survival vs placebo (P<.001; HR: 0.69; 95% CI, 0.55-0.87)¹

Nexavar extended median overall survival (OS) by 44% CI=confidence interval; HR=hazard ratio.
ªIntent-to-treat population.
  • Doubled time to tumor progression: 5.5 months vs 2.8 months with placebo
    (P<.001; HR: 0.58; 95% CI, 0.45-0.74)¹

44% 1-Year survival rate (n=299) vs 33% for placebo (n=303); P=.009¹

The SHARP Trial was stopped early for efficacy following a prespecified second interim analysis for survival showing a statistically significant advantage for Nexavar over placebo—this advantage was consistent across all subsets analyzed.

Important Safety Consideration

  • An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent discontinuation of Nexavar
*SHARP (Sorafenib HCC Assessment Randomized Protocol Trial): A randomized, double-blind, placebo-controlled, international, multicenter, phase 3 study in patients with unresectable HCC (N=602).¹ Read more about:


Reference: 1. Llovet JM, Ricci S, Mazzaferro V, et al; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378-390.