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Stivarga

Generic name: regorafenib
Treatment for: Colorectal Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma

Update: Stivarga (regorafenib) Now FDA Approved - September 27, 2012

NDA Submitted for Regorafenib

Bayer Submits New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer

WAYNE, N.J., May 23, 2012 /PRNewswire/ -- Bayer HealthCare announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC).

"Bayer HealthCare is pleased to have reached this development milestone in regards to filing with the FDA," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This is an important step toward our goal of bringing new treatment options to people living with cancer."

The submission is based on the results of a pivotal, global Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Results from the study were first presented at the Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and will be presented at the upcoming ASCO annual meeting in Chicago, IL (USA) in early June 2012.

Bayer has also submitted an application for European marketing authorization for regorafenib for the treatment of patients with mCRC.

About the CORRECT Study

The CORRECT study was an international, multicenter, randomized, double-blind, placebo-controlled Phase III study that enrolled 760 patients with mCRC whose disease had progressed during or within 3 months following last administration of approved standard therapies.[1]

Patients who had withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease were also allowed into the study.

Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. [2]

The study was conducted in North America, Europe, China, Japan and Australia.

About Colorectal Cancer

Colorectal cancer is a disease in which malignant (cancer) cells form in the tissues of the colon or rectum. The majority of cancers occurring in the colon and rectum are adenocarcinomas, which account for more than 90 percent of all large bowel tumors.[3]

CRC is the third most commonly diagnosed cancer and the third leading cause of cancer death in the United States, in both men and women.[4] It is estimated that more than 140,000 people will be diagnosed with CRC in 2011, and nearly 50,000 people will die from the disease.[5] Approximately 50 percent 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.[6]

About Regorafenib

Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Regorafenib is an investigational agent and is not approved by the FDA, EMA or other health authorities.

Regorafenib is one of several cancer compounds in Bayer's development pipeline. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statement

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

[1] A. Grothey, 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.

[2]. American Cancer Society. Colorectal Cancer Guide. Available from: http://www.cancer.org/acs/groups/cid/documents/webcontent/003096-pdf.pdf. Accessed on October 14, 2011.

[3] American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-028323.pdf. Accessed on October 24, 2011. Accessed on October 14, 2011.

[4] American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-028323.pdf. Accessed on October 24, 2011.

[5] National Cancer Institute. Colon and Rectal Cancer. Available at: http://www.cancer.gov/cancertopics/types/colon-and-rectal. Accessed on October 24, 2011.

[6] National Cancer Institute. Stage IV and Recurrent Colon Cancer. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional/page9. Accessed on October 24, 2011.

Posted: May 2012

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