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Phase 3 Trial of Nexavar in First-Line Advanced Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
Date:6/14/2010

ors as a single agent or combination treatment in a wide range of cancers, including lung, thyroid, breast, ovarian and colorectal cancer and as an adjuvant therapy for liver and kidney cancer.  

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma and advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed.  In HCC patients, bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo.   The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo.  In RCC patients, incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo.  Most common adverse events >/=20% related to Nexavar for both HCC and RCC were fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, nausea, and abdominal pain.  Grade 3/4 adverse events in HCC and RCC patients, respectively, were 45% for Nexavar vs. 32% for placebo and 38% for Nexavar and 28% for placebo.  Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding.  In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.


For information about Nexavar including U.S. Nexavar prescribing information, visit

SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
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