FDA Approved Drugs » 2012
Medical Areas: Gastroenterology | Nephrology | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bayer HealthCare Pharmaceuticals
Approval Status: Approved September 2012
Treatment Area: metastatic colorectal cancer
Stivarga (regorafenib) is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.
Stivarga is specifically approved for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
Stivarga is supplied as a tablet designed for oral administration. The recommended dose is 160 mg (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity. Stivarga should be taken at the same time each day. Swallow tablet whole with a low-fat breakfast (less than 30% fat).
FDA ApprovalThe FDA approval of Stivarga was based in part on an international, multi-center, randomized, double-blind, placebo-controlled trial in 760 subjects with previously treated metastatic colorectal cancer. The subjects received 160 mg Stivarga orally once daily plus Best Supportive Care (BSC) or placebo plus BSC for the first 21 days of each 28-day cycle. Stivarga was administered with a low-fat breakfast (less than 30% fat). The primary efficacy endpoint was overall survival (OS). The seconday endpoints included progression-free survival (PFS) and objective tumor response rate. The median overall survival was 6.4 months for the Stivarga arm versus 5.0 months for the placebo arm (p=0.0102). The median PFS was 2.0 months versus 1.7 months and the overall tumor response rate was 5 (1%) versus 1 (0.4%) for the Stivarga arm versus the placebo arm, respectively.
Adverse effects associated with the use of Stivarga may include, but are not limited to, the following:
Stivarga (regorafenib) is a potent oral multi-kinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). This distinct anti-angiogenic profile includes inhibition of both VEGFR2 and TIE2 TK.
Strumberg D, Scheulen ME, Schultheis B, Richly H, Frost A, Büchert M, Christensen O, Jeffers M, Heinig R, Boix O, Mross K Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study. British Journal of Cancer 2012 May 22;106(11):1722-7
For additional information regarding Stivarga or colorectal cancer, please visit the Stivarga-us web page.