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 is the first FDA-approved treatment for hepatocellular carcinoma (HCC) in a decade

STIVARGA is a once-daily, prescription anticancer medicine that you can take at home and has been shown to help patients previously treated with NEXAVAR® (sorafenib) live longer vs placebo, and prevent the cancer from progressing.

Liver Tumor Diagram

Improvement in Overall Survival

Clinical Trial Data Graphic

In clinical trials for HCC:

  • Patients taking STIVARGA (379) lived a median of 10.6 months compared to those taking placebo (194) who lived a median of 7.8 months
  • There were 233 deaths in the STIVARGA arm and 140 deaths in the placebo arm

Two common methods that doctors use to decide the prescribed medicine is working were used in the trials.

  1. RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 (RECIST 1.1), are the most widely used measures that focus on size and shrinkage of tumors.
  2. mRECIST (Modified Response Evaluation Criteria in Solid Tumors) use the RECIST model as a reference, but were developed specifically to study treatment of hepatocellular carcinoma (HCC) and have become the standard assessment when studying efficacy in treatment.

Using the RECIST 1.1 method, those patients taking STIVARGA (379):

  • Experienced a median progression-free survival (PFS) of 3.4 months. That's the length of time during treatment that a patient lives with cancer, but it does not get worse. Patients taking placebo (194) had a PFS of 1.5 months
    • Number of progressions or deaths: 288 of 379 (76%) in the STIVARGA arm; 184 of 194 (95%) in the placebo arm
  • Experienced an overall response rate (ORR) of 7% compared with 3% of the 194 patients taking placebo
    • 27 out of 379 patients (7%) had an ORR while taking STIVARGA vs 6 out of 194 patients (3%) who took placebo

Using the mRECIST method, those patients taking STIVARGA (379):

  • Experienced a median progression-free survival (PFS) of 3.1 months. That’s the length of time during treatment that a patient lives with cancer, but it does not get worse. Patients taking placebo (194) had a PFS of 1.5 months
    • 293 out of 379 patients (77%) progressed or died while taking STIVARGA vs 181 of 194 patients who took placebo (93%)
  • Had an overall response rate (ORR) of 11%. This is the proportion of patients who have a partial or complete response to therapy. Patients taking placebo (194) had an ORR of 4%
    • 42 out of 379 patients (11%) had an ORR while taking STIVARGA vs 8 out of 194 patients (4%) who took placebo

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.