Leverkusen, Germany-based Bayer submitted a new drug application to the FDA for Stivarga or Regorafenib, its second-line treatment for liver cancer patients, Tech Times reports.
Here's what you need to know.
1. The drug was successful in treating unresectable hepatocellular carcinoma in its clinical trials.
2. Regorafenib earned a Fast Track designation.
3. RESOURCE and phase III study researcher Jordi Bruix, MD, said the drug is the first treatment that demonstrates "overall survival benefit" in the second-line setting for cancer.
4. In the trial patients received the drug or a placebo once a day for three weeks on and one week off for 28 days. The tolerability and safety levels of the drug were consistent with its profile.
5. Dr. Bruiz believes the drug "shows promise" in changing the treatment landscape for patients on sorafenib.
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