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 gastrointestinal stromal tumor (GIST) 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.

How might STIVARGA® (regorafenib) work differently?

Cancer involves the uncontrolled growth of certain cells in the body.

How might STIVARGA® (regorafenib) work differently?

STIVARGA may hinder the signals that tell cancer cells to multiply, and may slow the cancer from spreading to other parts of the body.

How might STIVARGA® (regorafenib) work differently?

STIVARGA may also stop the creation of new blood vessels that feed cancer cells.

 

    CRC
    (Colon or Rectal Cancer)

    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.

    Overall survival data for STIVARGA® (regorafenib) in metastatic colorectal cancer

    Improvement in Overall Survival

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    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%)
    GIST
    (Gastrointestinal Stromal Tumor)

    STIVARGA for GIST

    STIVARGA is a once-daily, prescription anticancer medicine that you can take at home and has been shown to help previously treated patients with gastrointestinal stromal tumor (GIST), which is a rare stomach, bowel, or esophagus cancer) to prevent the cancer from progressing. STIVARGA is for patients who cannot be treated with surgery or who have had cancer spread to other parts of the body and have received previous treatment with certain medicines.

    Overall survival data for STIVARGA® (regorafenib) in gastrointestinal stromal tumor

    Improvement in Progression-Free Survival

    gist_image2

    In clinical trial for GIST:

    • The 133 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 4.8 months compared with 0.9 months of those taking placebo (66 patients)
      • This means that those on STIVARGA had a 73% reduction in the risk of disease progression or death compared with placebo
    • 82 of 133 STIVARGA patients (62%) vs 63 of 66 placebo patients (96%) experienced disease progression or died
      • In the GIST trial, there was no significant difference in overall survival (the length of time from when patients were enrolled in the study to death) from any cause vs placebo between patients taking STIVARGA and those on placebo, based on the 162 events for the final trial analysis
    HCC
    (Hepatocellular Carcinoma)

    STIVARGA for HCC

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

    Overall survival data for STIVARGA® (regorafenib) in hepatocellular carcinoma

    Improvement in Overall Survival

    Alt tag

    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 out of 379 patients with STIVARGA (62%) vs 140 deaths out of 194 patients with placebo (72%)

    Two common methods that doctors use to decide if 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
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    INDICATIONS

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

    • colon or rectal cancer 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

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

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    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:

    • have liver problems in addition to liver cancer
    • have bleeding problems
    • have high blood pressure
    • have heart problems or chest pain
    • plan to have surgery or have had a recent surgery. You should stop taking STIVARGA at least 2 weeks before planned surgery
    • are pregnant or plan to become pregnant. STIVARGA can harm your unborn baby. Females and males should use effective birth control during treatment with STIVARGA and for 2 months after their last dose of STIVARGA. Tell your healthcare provider right away if you or your partner becomes pregnant either while taking STIVARGA or within 2 months after your last dose of STIVARGA
    • are breast-feeding or plan to breast-feed. It is not known if STIVARGA passes into your breast milk. Do not breastfeed during treatment with STIVARGA and for 2 weeks after your final dose of STIVARGA

    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:

    • Infection. STIVARGA may lead to a higher risk of infections especially of the urinary tract, nose, throat and lung. STIVARGA may lead to a higher risk of fungal infections of the mucous membrane, skin or the body. Tell your healthcare provider right away if you get fever, severe cough with or without an increase in mucus (sputum) production, severe sore throat, shortness of breath, burning or pain when urinating, unusual vaginal discharge or irritation, redness, swelling or pain in any part of the body
    • severe bleeding. STIVARGA can cause bleeding, which can be serious and sometimes lead to death. Tell your healthcare provider if you have any signs of bleeding while taking STIVARGA, including: vomiting blood or if your vomit looks like coffee grounds, pink or brown urine, red or black (looks like tar) stools, coughing up blood or blood clots, menstrual bleeding that is heavier than normal, unusual vaginal bleeding, nose bleeds that happen often, bruising, and lightheadedness
    • a tear in your stomach or intestinal wall (bowel perforation). STIVARGA may cause a tear in your stomach or intestinal wall that can be serious and sometimes lead to death. Contact your healthcare provider immediately if you notice severe pains or swelling in your stomach area (abdomen), fever, chills, nausea, vomiting, or dehydration
    • a skin problem called hand-foot skin reaction and severe skin rash. Hand-foot skin reactions are common and sometimes can be severe. Tell your healthcare provider right away if you get redness, pain, blisters, bleeding, or swelling on the palms of your hands and soles of your feet, or a severe rash
    • high blood pressure. Your blood pressure should be checked every week for the first 6 weeks of starting STIVARGA. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are receiving STIVARGA. Tell your healthcare provider if you have severe headaches, light-headedness, or changes in your vision
    • decreased blood flow to the heart and heart attack. Get emergency help if you have chest pain, have shortness of breath, feel dizzy, or feel like passing out
    • a condition called reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you get severe headaches, seizure, confusion, change in vision, or problems thinking
    • risk of wound healing problems. Wounds may not heal properly during STIVARGA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with STIVARGA.
      • You should stop taking STIVARGA at least 2 weeks before planned surgery.
      • Your healthcare provider should tell you when you may start taking STIVARGA again after surgery.

    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.

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    Last updated on March 2024