Bayer’s second-line treatment for liver cancer, Stivarga, has gained the Korean government’s approval, the company said Monday.
Stivarga (ingredient: Regorafenib) won prior approval for treating colorectal cancer in patients who did not benefit from other treatments. Bayer expanded its indication to gain approval for the most common type of liver cancer, hepatocellular carcinoma, in April, the first approval of its kind in a decade.
During a media event to commemorate both the recent domestic and overseas approval, the company said Korea is the second country in Asia to sell the drug on the market, following Japan.
The drug is expected to benefit Korean patients with liver cancer, which is the fourth most commonly occurring cancer here, and the second leading cause of cancer-related deaths. Statistics show that liver cancer affects around 33 men and nine women per 100,000 people, putting the overall occurrence rate around 20 percent.
The domestic approval is another success for the company as another Bayer drug, Nexavar (ingredient: sorafenib) gained FDA approval for treating colorectal cancer drug as a first-line treatment.
“Bayer has succeeded in building up a solid pipeline for HCC with Nexavar from over 10 years ago now to Stivarga. I expect the allowance of Stivarga as a second-line treatment to bring hope to patients and their families,” said Ingrid Drechsel, CEO of Bayer Korea. “We will continue to lead the innovations in improving the quality of life for patients and are very proud to have Stivarga on the Korean market as of today.”
Clinical trials with 573 patients whose disease progressed despite first-line treatment proved the overall survival rate (OS) and the progression-free survival rate (PFS) improved in comparison to the placebo to stand at 10.6 months and 3.1 months, respectively. The placebo had an OS rate of 7.8 months and PFS of 1.5 months.
“The clinical trials show that the drug decreased the risk of death by 38 percent, and is thereby one of the few treatments that proved it could extend a patient’s survival rate,” said Professor Lim Ho-young of Samsung Medical Center.