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Sorafenib Granted Priority Review for the Treatment of Hepatocellular Carcinoma

WAYNE, N.J., and EMERYVILLE, Calif., Aug. 20 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals (NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced that the supplemental New Drug Application (sNDA) for Nexavar(R) (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, has been accepted for review and granted Priority Review status by the U.S. Food and Drug Administration (FDA). Nexavar is currently approved in more than 50 countries for the treatment of patients with advanced kidney cancer.

Priority Review designation is intended to expedite the regulatory review process for investigational agents or uses that address unmet medical needs. Based on this designation, the FDA reviews the application with a goal of taking action within six months of the date on which they received the sNDA.

"This Priority Review underscores the potential of Nexavar to be a significant advance in the treatment of liver cancer," said Susan Kelley, M.D., vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "If approved, Nexavar would be the first FDA-approved therapy for patients battling this devastating disease."

The sNDA submission, completed in June 2007, was based on data from the Phase 3 SHARP trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on this data, the companies also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in June.

"The incidence of liver cancer continues to rise in the United States and around the world, highlighting the significant need for new therapies," said Hank Fuchs, executive vice president and chief medical officer of Onyx. "Our comprehensive development program continues to identify new areas where Nexavar's unique combination of multi-targeted activity, tolerability and oral dosing may meet additional unmet needs in cancer."

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.(3) Over 600,000 cases of liver cancer are diagnosed globally each year(3) (about 19,000 in the United States(4) and 32,000 in the European Union(5)) and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of liver cancer.(6)

Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with 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. 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 treatment-emergent adverse events with Nexavar in patients with advanced kidney cancer were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 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 U.S. Nexavar prescribing information, visit or call 1.866.NEXAVAR (1.866.639.2827).

1. World Health Organization. Hepatitis B. Available at: Accessed April 10, 2007
2. Penn State Milton S. Hershey Medical Center College of Medicine. Malignant Hepatoma. Available at: Accessed April 10, 2007.
3. International Agency for Cancer Research. GLOBOCAN 2002. Available at: http://www/ Accessed April 23, 2007.
4. Jemal A et al. CA Cancer J Clin. 2007;57:43-66.
5. International Agency for Cancer Research. EUCAN 1998. Available at: Accessed April 26, 2007.
6. Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: Accessed April 10, 2007.

Source: Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals

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