Advertisement
"The positive opinion issued by the CHMP marks another significantmilestone for Nexavar in liver cancer," said Gunnar Riemann, Ph.D., member ofthe Bayer HealthCare Executive Committee. "The Committee's decisionunderscores the potential of Nexavar to become the standard systemic drugtherapy for the treatment of liver cancer."
Advertisement
The CHMP positive opinion was based on data from the Phase 3 Sorafenib HCCAssessment Randomized Protocol (SHARP) trial which demonstrated that Nexavarextended overall survival by 44 percent in patients with HCC (HR=0.69;p=0.0006) versus placebo. There were no meaningful differences in seriousadverse event rates between the Nexavar and placebo-treated groups with themost commonly observed serious adverse events in patients receiving Nexavarbeing diarrhea and hand-foot skin reaction. Based on these data, asupplemental New Drug Application for Nexavar was also granted Priority Reviewstatus by the U.S. Food and Drug Administration (FDA) in August.
"This decision, coupled with the Priority Review status granted by theFDA, means that patients in these regions are one step closer to a newtreatment for their liver cancer," said Hollings Renton, chairman, presidentand chief executive officer of Onyx Pharmaceuticals, Inc.
HCC, the most common form of liver cancer, is responsible for about 90percent of the primary malignant liver tumors in adults.(1,2) Liver cancer isthe sixth most common cancer in the world and the third leading cause ofcancer-related deaths globally.(3) Over 600,000 cases of liver cancer arediagnosed globally each year(3) (about 19,000 in the United States(4) and32,000 in the European Union(5)) and in 2002 approximately 600,000 people diedof liver cancer including 13,000 in the United States, 57,000 in Europe andapproximately 360,000 in China, Korea and Japan.(6)
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinicalstudies, Nexavar has been shown to target members of two classes of kinasesknown to be involved in both cell proliferation (growth) and angiogenesis(blood supply) -- two important processes that enable cancer growth. Thesekinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has arole in HCC; therefore blocking signaling through Raf-1 may offer therapeuticbenefits in HCC.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment ofpatients with advanced kidney cancer, hypertension may occur early in thecourse of therapy and blood pressure should be monitored weekly during thefirst six weeks of therapy and treated as needed. Incidence of bleedingregardless of causality was 15% for Nexavar vs. 8% for placebo and theincidence of treatment-emergent cardiac ischemia/infarction was 2.9% forNexavar vs. 0.4% for placebo. Most common treatment-emergent adverse eventswith Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skinreaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavarvs. 28% for placebo. Women of child-beari
