Sorafenib (Nexavar) Okayed for Inoperable Liver Cancer


ROCKVILLE, Md., Nov. 20 -- The FDA has given sorafenib (Nexavar) an indication for unresectable hepatocellular carcinoma on the basis of a three-month survival edge and improved time to progression.
The drug, an oral kinase inhibitor, was previously approved two years ago for advanced renal cell carcinoma.
The significant improvements in survival and time to progression that led to approval were demonstrated by an international, multicenter, randomized, double-blind, and placebo-controlled trial, the agency said.
"This is an important new treatment option for patients who are fighting this very difficult form of cancer," said Robert Justice, M.D., director of FDA's division of oncology drug products.
"The group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug," Dr. Justice said.
That trial, involving 602 volunteers, was stopped early following a planned interim analysis, which showed a statistically significant survival advantage for sorafenib -- a median of 10.7 versus 7.9 months. The hazard ratio was 0.69, with a 95% confidence interval from 0.55 to 0.87, which was significant at P=0.00058.
The trial also showed time to progression was significantly improved in the sorafenib arm -- a median of 5.5 months versus 2.8. The hazard ratio was 0.58, with a 95% confidence interval from 0.45 to 0.74, which was significant at P=0.000007.
The most common drug-related adverse reactions -- seen in more than 20% of volunteers -- were fatigue, weight loss, rash or desquamation, hand-foot skin reaction, alopecia, diarrhea, anorexia, nausea, and abdominal pain.