Nexavar Approved by FDA The US Food and Drug Administration (FDA) has approved Nexavar for patients with liver cancer.

Nexavar Approved by FDA

By Steven Chu
Nov 19, 2007 19:52 PM GMT
Nexavar Approved by FDA

The US Food and Drug Administration (FDA) has approved Nexavar for patients with liver cancer.

It is the first approved systemic drug therapy for liver cancer, as well as being the only medication therapy proven to significantly improve overall survival in liver cancer patients.

Last month Nexavar was approved in Europe for HCC treatment. The drug is approved in more than 60 countries worldwide. It is the first new treatment for advanced new kidney cancer in over ten years.

HCC accounts for 90percent of the primary malignant liver tumors in adults, it is also the most common form of liver cancer. Liver cancer is the third leading cause of cancer-related deaths worldwide, and the sixth most widespread cancer globally. 600,000 people annually are diagnosed with liver cancer worldwide, and its incidence is rising. 19,000 people in the USA, 54,000 in Europe, and 390,000 in China, Korea and Japan are diagnosed with liver cancer each year.

Positive data from the international Phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial demonstrated to the FDA that the drug should be approved. The trial showed that Nexavar gave patients an improved overall survival of 44 percent, compared to a placebo. The median overall survival was 10.7 months for the patients receiving Nexavar, versus 7.9 months for those on the placebo.

Imbalances in serious adverse event rates between Nexavar and the placebo groups were not observed. Diarrhea and hand/foot skin reactions were the most common side effects experienced by the Nexavar patients.

Filed Under:   Cancer News   Current Health News


Share and Enjoy:
Digg StumbleUpon Buzz del.icio.us Facebook NewsVine Reddit YahooMyWeb Google Bumpzee Furl Mixx

The US Food and Drug Administration (FDA) has approved Nexavar for patients with liver cancer.