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Regorafenib Seeks Approval For Liver Cancer Treatment from FDA

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  • German drugmaker submits supplemental new drug application for regorafenib in the treatment of advanced stage liver cancer.
  • Regorafenib is a multi kinase inhibitor which blocks proteins and stops the growth of cancer cells.
  • Phase 3 clinical trial shows regorafenib to be an effective treatment option for liver cancer when compared to placebo.

Regorafenib Seeks Approval For Liver Cancer Treatment from FDA

German pharma company Bayer has submitted a supplemental new drug application to the Food and Drug Administration (FDA).

The company has submitted regulatory applications seeking approval for Regorafenib to be used for the second-line treatment of liver cancer.


Liver is the largest internal organ in the body and abnormal proliferation of cells in the liver without control may lead to liver cancer.

According to the American Cancer Society, about 39,230 new cases of liver cancer and bile duct cancer will be diagnosed in the United States by 2016.

Liver cancer is found to be more common in men than women.

Regorafenib (Stivarga) is a tyrosine kinase inhibitor which is used for the treatment of bowel or stomach sarcoma and is under clinical trials for treating various other cancers.

The drug acts by blocking the different number of proteins which allows the cancer cells to grow. It is also known as the multi kinase inhibitor.

The drug company has submitted the supplemental new drug application based on the findings of phase 3 RESORCE clinical trial. The study results suggested an overall survival rate of 10.6 months with regorafenib and supportive care treatment when compared to only 7.8 months for placebo drug.

This shows a 38% reduction in the risk of death due to liver cancer.

Jordi Bruix, MD, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain, lead researcher of the trial said,"Regorafenib is the first treatment to demonstrate overall survival benefit in the second-line setting for unresectable Hepatic Cell Carcinoma in clinical trials and, if approved, has the potential to change the treatment landscape for patients who progress on sorafenib."

The randomized trial was carried on 573 patients with Hepatic Cell Carcinoma (HCC) who received regorafenib and placebo drug with supportive care treatment. The average age of the patient was 63 years and around 88% of them were male candidates.

Regorafenib was administered at a dose of 160mg once daily for 3 weeks followed by 1 week without any treatment. These patients had a previous treatment with greater than 400mg/day of sorafenib (Nexavar) drug for more than 20 days.

The overall survival, progression free survival, objective response rate was found to be high with regorafenib when compared to the placebo.

However, side effects like hypertension, hand-foot skin reaction, diarrhea and fatigue were noted among regorafenib patients.

Dario Mirski, MD, senior vice president and head of Medical Affairs for the Americas at Bayer said, "For nearly a decade and counting, Bayer has been committed to meeting the needs of those with liver cancer with our proven first-line systemic therapy in unresectable HCC patient's therapy, Nexavar."

"Clearly, more options are needed for these patients, especially in the second-line setting. The filing of Stivarga in HCC demonstrates our commitment to ongoing research in this difficult-to-treat cancer."

Source: Medindia

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