IMPORTANT SAFETY INFORMATION:
NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR. Continue reading below

NEXAVAR in unresectable HCC

OS in the SHARP* trial1,2

NEXAVAR significantly extended OS vs placebo in the SHARP clinical trial1,2

NEXAVAR® (sorafenib) Phase III Trial Efficacy Results Chart

*SHARP (Sorafenib HCC Assessment Randomized Protocol): a randomized, double-blind, placebo-controlled, international, multicenter, phase III trial in patients with unresectable HCC (N=602).1


OS advantage of NEXAVAR demonstrated across patient subsets analyzed in the SHARP pivotal trial

NEXAVAR® (sorafenib) Phase III Trial Efficacy Results Chart

ECOG, Eastern Cooperative Oncology Group.

The trial was not powered to assess differential patient response to treatment by subsets, and no adjustments were made for multiple comparisons. The univariate, exploratory subset analyses were intended to be descriptive only. Therefore, the results of these descriptive analyses cannot be used to conclude whether a real difference in treatment effect exists between subsets.2,3

Indications

NEXAVAR is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

Important Safety Information

For important risk and use information about NEXAVAR, please see the full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION for STIVARGA® (regorafenib)

For important risk and use information about STIVARGA, please see the full Prescribing Information including the Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

REFERENCES:

1. NEXAVAR Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc; 2015. 2. Llovet JM, Ricci S, Mazzaferro V, et al; for SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378-390. 3. Data on file. Bayer HealthCare Pharmaceuticals, Inc. November 2007-May 2016.