German pharmaceutical company Bayer is seeking the approval of federal health regulators to have its drug Stivarga (Regorafenib) as second-line treatment for liver cancer patients.
On Monday, Bayer submitted a New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) following successful clinical trials for regorafenib in treating unresectable hepatocellular carcinoma (uHCC).
Bayer, which is known for its manufacture of aspirin, asked authorities in the U.S., Europe and Japan to expand the market authorization of regorafenib, which is already used to treat gastrointestinal stromal tumors and colorectal cancer.
Incidence Of Liver Cancer
Liver cancer is considered as the second primary cause of cancer-related deaths worldwide.
In fact, around the world, nearly 780,000 patients are diagnosed with unresectable hepatocellular carcinoma every year, with the number continuing to increase.
The disease is also the fifth most common cancer among men globally, while it is the ninth most common cancer among women.
In the U.S., cases of liver cancer have tripled since the 1980s, with at least 39,000 new cases estimated to be diagnosed this year. In 2012, nearly 746,000 patients died of liver cancer, including 48,000 in Europe, 24,000 in the U.S., and 477,000 in the Western Pacific Region.
Dario Mirski, senior vice president at Bayer, says more choices are clearly needed for liver cancer patients, particularly in the second-line treatment.
Mirski says the filing of regorafenib in HCC shows the company's commitment to ongoing research for liver cancer, which is considered as a difficult-to-treat cancer.
Effective Second-line Treatment
Regorafenib was accepted for an expedited approval process in the U.S. known as Fast Track designation.
Dr. Jordi Bruix, who took part in the RESORCE study and phase III SHARP study that investigated regorafenib, says it is the first treatment that demonstrates overall survival benefit in second-line setting for liver cancer in clinical trials.
During the trials, patients were given either 160 mg of reforanerib once daily or placebo for three weeks on, and another week off, for 28 days, which constitutes a complete treatment cycle.
The main endpoint of the clinical trial was overall survival, while the secondary endpoints were progression-free survival, time to progression, disease control rate and objective tumor response rate. In the end, Bruix and colleagues found that the tolerability and safety levels were consistent with the profile of Stivarga.
Meanwhile, Bruix believes that, if regorafenib is approved, it shows promise in shifting the treatment landscape for patients who advance on sorafenib, which is used to treat advanced primary liver cancer.