U.S. Food and Drug Administration has approved Stivarga (regorafenib) tablets for the treatment of patients suffering from metastatic colorectal cancer (mCRC) who were unable to get significant relief from currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy) as announced by Bayer HealthCare (BYR.L, BAYRY.PK, BAYZF.PK) and Onyx Pharmaceuticals Inc.
Colon and rectum cancer is the third most common type of cancer in USA. It is estimated that approximately 140,000 men and women are being affected by colon and rectum cancer each year according to the American Cancer Society.
“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research, said in the statement.
The estimated sale of Stivarga in 2016 may be $536 million for Bayer and $251 million for Onyx according to the analysis made by Bloomberg.
This approval granted by FDA is based on pivotal Phase III study (CORRECT) that has shown significant improvement in overall survival rate (OS) and progression-free survival (PFS) in comparison to placebo.
“The approval of regorafenib adds to the treatments we have for metastatic colorectal cancer, which is important for those patients who have no further options,” said Heinz-Josef Lenz, MD, FACP, CORRECT investigator and associate director for clinical research and co-leader of the Gastrointestinal Cancers Program at the USC Norris Comprehensive Cancer Center. “The drug has been shown to prolong survival and slow the progression of cancer in patients whose disease has progressed after treatment with currently available therapies. It provides patients another avenue to fight this cancer.”
The most frequent side effects of Stivarga include loss of appitite and food intake, asthenia, hand-foot-skin reactions, diarrhea, weight loss, infection, dysphonia and hypertension. It may cause some serious side effects such as gastrointestinal perforation, hepatotoxiciy and hemorrhage.
“The approval of Stivarga reflects Bayer’s commitment to confronting the challenges of difficult-to-treat cancers,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “Patients with metastatic colorectal cancer whose disease has returned after treatment will now have a new option that has been shown to prolong survival and keep the cancer from progressing.”
Stivarga is an inhibitor of multi-kinases that are necessary for the growth and progression of tumor. Oncogenesis, tumor microenvironment, and angiogenesis. It can also inhibit ngiogenic VEGF receptor tyrosine kinases that cause tumor neoangiogenesis (the growth of new blood vessels).
Get full prescribing information of Stivarga here.
Source: Onyx Pharmaceuticals, Inc
- STIVARGA Prescribing Information. September 2012
- 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.
- 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.
- American Cancer Society. Colorectal Cancer. Available at: http://www.cancer.org/Cancer/ColonandRectumCancer/DetailedGuide/colorectal-cancer-key-statistics. Accessed on August 3, 2012.
- National Cancer Institute. Colon Cancer Treatment. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional/page9. Accessed on August 3, 2012.
- Genetics Home Reference (A Service of the U.S. National Library of Medicine). Gene Summary on the KRAS Gene. Available at: http://ghr.nlm.nih.gov/gene/KRAS. Accessed on May 18, 2012.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Colon Cancer. Version 3.2012.
Copyright 2012 Medimoon.com. All rights reserved. No part of this site can be reproduced without our written permission.