Nexavar® (sorafenib) has been added to the list of treatment options for patients with hepatocellular carcinoma (HCC) who are not eligible for a liver transplant. The rationale for approval was reported in a recent presentation at the annual conference of the National Comprehensive Cancer Network (NCCN).

Nexavar is an orally active, multi-kinase inhibitor approved for the treatment of advanced renal cell carcinoma. Recently reported results from a large clinical trial, referred to as the SHARP trial, indicated that Nexavar doubled the survival of patients with advanced HCC. Another recent trial showed that patients with advanced HCC from China, Korea, and Taiwan benefited from Nexavar. As well, one study has shown that the addition of Nexavar to doxorubicin improved outcomes of patients with advanced HCC compared with doxorubicin alone. The FDA approved Nexavar for the treatment of inoperable HCC in November of 2007.

The following results of a randomized trial comparing Nexavar with placebo in patients with advanced HCC were summarized in the presentation at the annual conference of the NCCN:

• Time to disease progression for the patients taking the placebo was only 12.3 weeks compared with 24 weeks for the patients using Nexavar, a 73% improvement. 
• Overall survival for patients on Nexavar was 46.4 weeks compared with 34.4 weeks for patients in the placebo group, representing a 44% improvement in overall survival.

According to this recent presentation, Nexavar has been added as an option at several points in the treatment plan for HCC. Nexavar may be utilized for patients who are not candidates for liver transplant, for those who have a good overall health status, or for patients who are ineligible for surgery due to poor overall health or other illnesses.

Comments: This report summarizes the state of knowledge about Nexavar for the treatment of patients with advanced HCC and is in line with FDA guidelines.

Related News:

Nexavar® Effective for Patients with Hepatocellular Carcinoma (10/1/2007)

Nexavar® and Doxorubicin More Effective than Doxorubicin Alone for Hepatocellular Carcinoma (9/28/2007)

Nexavar® Improves Liver Cancer Survival Among Asians (8/31/2007)

Nexavar® Improves Survival in Hepatocellular Carcinoma (6/5/2007)

Reference: National Comprehensive Cancer Network. Hepatobiliary Cancers: Summary of the Guidelines Update. Available at: www.nccn.org. Accessed March 2008.