STATES CHRONICLE – A new cure for cancer developed by scientists from Bayer requested the approval of FDA. Bayer had announced that a medical supplemental treatment New Drug Application (sNDA) for the drug known as Stivarga was submitted for approval to the US Food and Drug Administration. The meds were meant to be used for a systematic treatment of patients suffering from unresectable hepatocellular carcinoma (uHCC).
Stivarga was already approved to be used in treating patients diagnosed with metastatic colorectal cancer who were dealt with in the past with chemotherapy. The chemotherapy treatment was based on irinotecan, oxaliplatin, and fluoropyrimidine bound to be categorized as an anti-VEGF therapy. In case RAS type of the disease appeared, then other treatments were used, like anti-EGFR therapy. This new cure for cancer was also designed to treat those patients who suffered from gastrointestinal stromal tumor (GIST).
Every year, around the world, almost 780,000 people are diagnosed with HCC. The number of patients with HCC is continuously increasing. Since 1980, in the US, the cases of liver cancer have risen to triple the number. That is an alarming situation which should make people aware of the risks. Over 39,000 new cases have appeared in 2016. Studies have categorized liver cancer to be the second one on the list of leading cause of cancer-related deaths.
Dario Mirski, who is the head of medical affairs for the Americas and the Bayer’s senior vice president, has claimed that Bayer has been involved in fulfilling the need of liver cancer patients treating them with their systematic therapy, Nexavar. He also asserted that the presence of Stivarga in HCC had proved their dedication to the research prone to discover the new cure for cancer.
The data meant to help at the submission of the sNDA was obtained after conducting the Phase III RESORCE trial. This trial was designed to investigate the effects of Stivarga in patients suffering from uHCC and whose illness has registered progress after they were treated with Nexavar pills.
Dr. Jodi Bruix, who is the Principal Investigator of the RESORCE study, has claimed that regorafenib was the first drug to prove the survival benefit for those patients with unresectable HCC present in clinical trials. If this medication gets its approval, it will change the view on treatments for those patients who registered progress on sorafenib.
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