MultiVu Video Feed: Bayer's Stivarga®(regorafenib) Tablets Approved By U.S. FDA for Treatment Of Metastatic Colorectal Cancer

NEWS:  The U.S. Food and Drug Administration Approved Bayer's Stivarga® (regorafenib) Tablets for Treatment of Patients with Metastatic Colorectal Cancer Who Have Been Previously Treated with Currently Available Therapies

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The U.S. Food and Drug Administration has approved Stivarga®(regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy).1

Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment.1

The approval of Stivarga is based on results from the pivotal Phase III study (CORRECT) that demonstrated improvement in overall survival and progression-free survival compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies.2,3

Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the United States, in both men and women. It is estimated that more than 143,000 people will be diagnosed with CRC in 2012, and nearly 52,000 people will die from the disease.4 Approximately 50% of colon cancer patients will be diagnosed with metastases (most commonly to the liver) either at the time of diagnosis or due to recurrent disease.5

For full prescribing information, including BOXED WARNINGS, visit  

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  • Dr. Heinz-Josef Lenz, Professor of Medicine and Preventive Medicine at the USC Keck School of Medicine; Associate Director of Clinical Research at the USC Norris Comprehensive Cancer Center in Los Angeles
  • Dr. Pamela A. Cyrus, Vice President and Head of U.S. Medical Affairs Bayer HealthCare Pharmaceuticals

VIDEO PROVIDED BY:   Bayer Healthcare Pharmaceuticals, Inc.

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Important Safety Information for Stivarga (regorafenib)

WARNING: HEPATOTOXICITY: Severe and sometimes fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.

Obtain liver function tests (ALT, AST, and bilirubin) before initiation of Stivarga and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values.

In clinical trials, Stivarga was associated with an increased incidence of hemorrhage, including fatal hemorrhage. Permanently discontinue Stivarga in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.

Hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and rash are the most frequently observed dermatological reactions with Stivarga. Temporarily hold and then reduce or permanently discontinue Stivarga depending on the severity and persistence of dermatologic toxicity.

An increased incidence of hypertension has been observed with Stivarga. Do not initiate Stivarga until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold Stivarga for severe or uncontrolled hypertension.

Stivarga has been associated with an increased incidence of myocardial ischemia and infarction. Withhold Stivarga in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events.

Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported with Stivarga. Confirm the diagnosis of RPLS with MRI and discontinue Stivarga in patients who develop RPLS.

Gastrointestinal perforation and fistula have been reported in patients treated with Stivarga. Permanently discontinue Stivarga in patients who develop gastrointestinal perforation or fistula.

Treatment with Stivarga should be stopped at least 2 weeks prior to scheduled surgery. The decision to resume regorafenib after surgery should be based on clinical judgment of adequate wound healing. Stivarga should be discontinued in patients with wound dehiscence.

Stivarga can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

The most frequently observed adverse drug reactions (greater than or equal to 30%) in Stivarga-treated patients vs placebo-treated patients, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).


  1. STIVARGA Prescribing Information. September 2012.
  2. Grothey, A et al. Results of a randomized Phase 3 trial (CORRECT) of regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with mCRC who have progressed after standard therapies [January 17, 2012 ASCO-GI Presscast Presentation]. 2012 Gastrointestinal Cancers Symposium; January 19-21, 2012. San Francisco, CA.
  3. Van Cutsem, E, et al. Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC) [Presentation]. 2012 American Society of Clinical Oncology; June 1-5, 2012. Chicago, IL.
  4. American Cancer Society. Colorectal Cancer. Available at: Accessed on August 3, 2012.
  5. National Cancer Institute. Colon Cancer Treatment. Available at: Accessed on August 3, 2012.

/PRNewswire/ -- Sept. 27, 2012/

SOURCE Bayer Healthcare Pharmaceuticals, Inc.