IMPORTANT SAFETY INFORMATION: STIVARGA can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests... Continue reading below
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What is STIVARGA® (regorafenib)

STIVARGA is a once-daily, oral prescription anticancer medicine approved by the FDA for people with:

  • colon or rectal cancer (CRC) that has spread to other parts of the body and for which they have received previous treatment with certain chemotherapy medicines
  • a rare stomach, bowel, or esophagus cancer called GIST (gastrointestinal stromal tumor) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines
  • a type of liver cancer called hepatocellular carcinoma (HCC) in people who have been previously treated with sorafenib

How might STIVARGA work differently as a multikinase inhibitor?

STIVARGA is a systemic therapy that works throughout your body to help fight certain cancers. STIVARGA, a multikinase inhibitor, may work by blocking some proteins on certain normal and cancer cells. In this way, STIVARGA may prevent cancers from developing and spreading for a period of time.

growth
Cancer involves the uncontrolled growth of certain cells in the body.
growth
STIVARGA may hinder the signals that tell cancer cells to multiply, and may slow the cancer from spreading to other parts of the body.
growth
STIVARGA may also stop the creation of new blood vessels that feed cancer cells.
HCC Hepatocellular Carcinoma
CRC Colon or Rectal Cancer
GIST Gastrointestinal Stromal Tumor

STIVARGA for CRC

STIVARGA is a once-daily, prescription anticancer medicine for patients who have received previous treatment with certain chemotherapy medicines to treat colon cancer (CRC) that has now spread to other parts of the body. STIVARGA can be taken at home and has been shown to help some patients live longer and prevent the cancer from progressing vs placebo.

Intestine Tumor Diagram

Improvement in Overall Survival

Clinical Trial Data Graphic

In the clinical trial of patients with metastatic CRC (mCRC)

  • STIVARGA increased overall survival—or the length of time from when patients were enrolled into the study to death from any cause vs placebo
  • The 505 patients taking STIVARGA lived a median of 6.4 months compared with the 255 patients on placebo, who lived a median of 5 months
  • There were 275 deaths out of 505 patients with STIVARGA (55%) vs 157 deaths out of 255 patients with placebo (62%)
  • In addition, patients taking STIVARGA experienced a median progression-free survival, or PFS, (the length of time during treatment that a patient lives with cancer but it does not get worse) of 2 months compared to 1.7 months for those taking placebo
    • This means those on STIVARGA had a 51% reduction in the risk of disease progression or death compared with placebo
  • 417 of 505 STIVARGA patients (83%) vs 231 of 255 placebo patients (91%) progressed or died
  • Patients taking STIVARGA had a greater overall response rate (reduction in tumor size) than patients who took placebo, 5 (1%) compared to 1 (0.4%)

Indications

STIVARGA (regorafenib) is a prescription medicine used to treat people with:

It is not known if STIVARGA is safe and effective in children less than 18 years of age.

Important Safety Information

STIVARGA (regorafenib) can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems. Tell your healthcare provider right away if you experience yellowing of your skin or the white part of your eyes, nausea, vomiting, dark urine, or change in your sleep pattern.

Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Avoid drinking grapefruit juice and taking St. John’s Wort while taking STIVARGA.

STIVARGA may cause serious side effects, including:

The most common side effects with STIVARGA include pain including stomach-area (abdomen); tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); decreased appetite; infection; voice change or hoarseness; increase in certain liver function tests; fever; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); and weight loss.

For important risk and use information about STIVARGA, please see the full Prescribing Information, including Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.