WAYNE, N.J. and EMERYVILLE, Calif., Nov. 19 Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX)today announced that the U.S. Food and Drug Administration (FDA) has approveda supplemental New Drug Application for Nexavar(R) (sorafenib) tablets for thetreatment of patients with unresectable hepatocellular carcinoma (HCC), orliver cancer. Nexavar, an oral anticancer drug, is the first approvedsystemic therapy for liver cancer and the only one shown to significantlyimprove overall survival in patients with the disease. In 2005 Nexavar becamethe first new treatment in more than a decade for advanced kidney cancer, andis currently approved in more than 60 countries for this indication.
"The approval of Nexavar in liver cancer marks the second time in twoyears that this novel kinase inhibitor has been granted FDA approval on aPriority Review basis, making it rapidly available to patients who previouslyhad limited treatment options," said Arthur Higgins, chairman of the ExecutiveCommittee of Bayer HealthCare. "This milestone will likely establish Nexavaras the standard systemic therapy for the treatment of liver cancer, and is aturning point in improving treatment outcomes in patients facing thedevastating impact of this disease."
"Liver cancer is one of the cancers in which the number of related deathscontinues to increase," said Hollings C. Renton, chairman, president and chiefexecutive officer of Onyx Pharmaceuticals, Inc. "This second approval forNexavar demonstrates our commitment to expediting the clinical development ofthis innovative therapy to treat today's unmet needs in cancer. We aregrateful to the patients, families and investigators who make this importantresearch possible."
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) More than 600,000 cases of liver cancerare 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)) andincidence is increasing.(7) In 2002 approximately 600,000 people died ofliver cancer including 13,000 in the United States, 57,000(5) in Europe andapproximately 360,000 in China, Korea and Japan.(6) Currently, the 5-yearsurvival rate for liver cancer patients in the United States is 11 percent.(8)
"The American Liver Foundation (ALF) is always pleased when new therapiesprove 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 LiverFoundation. "This new treatment provides a valuable option for liver cancerpatients and will enable ALF to further promote the treatment of liver diseasethrough our education and advocacy efforts."
The companies also announced that an innovative patient support program -Resources for Expert Assistance and Care Helpline (REACH(R)) - is available toanswer questions about Nexavar treatment, reimbursement, and patient support.For more information, healthcare providers and patients may contact the REACHprogram at 1.866.NEXAVAR (1.866.639.2827).
Phase 3 Data Summary
The FDA approval was based on positive data from the international Phase 3placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trialwhich demonstrated that Nexavar improved overall survival by 44 percent inpatients with HCC (HR=0.69; p=0.0006) versus placebo. In the study, medianoverall survival was 10.7 months in Nexavar-treated patients compared to 7.9months in those taking placebo. No indication of imbalances was observed inserious adverse events between the Nexavar and placebo-treated groups with themost co