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FDA Approves Nexavar As First Drug Treatment for Liver Cancer

Armen Hareyan's picture

Nexavar becomes the first FDA-approved drug treatment therapy for patients suffering from liver cancer. Nexavar is made by Bayer Healthcare and the FDA liver cancer treatment node was announced today.

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.

"The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer, and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease."

"Liver cancer is one of the cancers in which the number of related deaths continues to increase," said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. "This second approval for Nexavar demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today's unmet needs in cancer. We are grateful to the patients, families and investigators who make this important research possible."

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) More than 600,000 cases of liver cancer are diagnosed worldwide each year(3) (about 19,000 in the United States,(4) 54,000(5) in Europe,(6) and 390,000 in China, Korea and Japan(6)) and incidence is increasing.(7) In 2002 approximately 600,000 people died of liver cancer including 13,000 in the United States, 57,000(5) in Europe and approximately 360,000 in China, Korea and Japan.(6) Currently, the 5-year survival rate for liver cancer patients in the United States is 11 percent.(8)

"The American Liver Foundation (ALF) is always pleased when new therapies prove effective for those affected by liver disease. Researchers worldwide, including those supported by ALF, have spent decades studying liver cancer," said James L. Boyer, M.D., chairman, board of directors, American Liver Foundation. "This new treatment provides a valuable option for liver cancer patients and will enable ALF to further promote the treatment of liver disease through our education and advocacy efforts."

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The companies also announced that an innovative patient support program - Resources for Expert Assistance and Care Helpline (REACH(R)) - is available to answer questions about Nexavar treatment, reimbursement, and patient support. For more information, healthcare providers and patients may contact the REACH program at 1.866.NEXAVAR (1.866.639.2827).

Nexavar Phase 3 Data Summary

The FDA approval was based on positive data from the international Phase 3 placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar improved overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. In the study, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. No indication of imbalances was observed in serious adverse events 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 these data, the European Commission granted marketing authorization to Nexavar for the treatment of patients with hepatocellular carcinoma on October 29, 2007.

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 unresectable hepatocellular carcinoma, 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. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar vs. 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% 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 www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).



I am currently taking Nexavar (800 mg), after sutent did not work for GIST metastic Liver Cancer. I have been on Nexavar for a little over one week and experiencing more fatigue than I did on Sutent. Anyone undergoing Nexavar for GIST Metastic Liver Cancer please tell of any success that you are having with the drug. e-mail '[email protected] thank you
this medicine does not work, my mom was hospitalized after 5 days from taking NEXAVAR and now has kidneys problems, pancreas problems and finally after another 2 weeks of taking it they kicked her out of hospital because the corruptions of this damn medicine and they told her to stop taking it and put her on hospice waiting for her death any time now, I hate NEXAVAR, I hate Doctors, I hate Hospitals and I hate every one contributes in my mom`s health conditions to be worse, it breaks my heart to see my mother after she was full of life now she is broken and helpless because of this NEXAVAR. if you want call me to tell you more about the killer medicine. Fred Benjamin 951-738-8655
There are risks with any and all forms of cancer treatment. I am on nexavar and have been since October.....with minimal side effects. For you to write that and literally scare the hell out of people is just wrong. I am sorry for what you are going thru with your mother. I lost my sister in August to a different type of cancer and I understand the anger you are feeling. I pray that someone can help ......
Hi my name is wendy and my mom is has heptocelluar carcinoma and is taking nexavar for about 8 moths and so far she doing good but her liver not showing any improvements so far but know shes getting a little weak.
I read and read .........what is the difference between HCC and Cholangiocarcinoma I read that HCC is most common form of liver cancer and that cholangiocarcinoma is rare Yet am being treated with nexavar for reoccurence of my cholangiocarcinoma Is there anyone else being treated as such?
can I please have an e-mail account in order to communicate with you. my father was also diagnosed with cholangiocarcinoma and the doctors also prescribed him nexavar. i'm interested for how long you have been treated with this medicine and what favorable evolution you have. thank you very much
my husband was dx with primary liver cancer oct 2008. he started nexavar dec 2008. so far the side effects have been mininal mostly weight loss and fatigue. our options are few in fightn this diease we are considering chemo beads since the rad beads are not an option for him. if any one has had the chemo beads we would love to hear from you regardless of your success. thanks
3 years ago i was diagnosed with stage4 liver cancer by taking nexavar iam cancer free would like to talk to anyone who has liver cancer e mail is [email protected]
Congradulations to you Wally! my dad was same diagnoses hope it works the same for him are you still using nexavar?
hi, congrates for being curesdid you only use naxavar for treatment of liver cancerare you sure only nexavar cure your tumor,as we know it only slow tumor growth ,not kill tumor cell,s waiting for reply