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Stivarga Approval History

FDA Approved: Yes (First approved September 27, 2012)
Brand name: Stivarga
Generic name: regorafenib
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Colorectal Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma

Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.

Development History and FDA Approval Process for Stivarga

DateArticle
Apr 27, 2017Approval FDA Expands Approved Use of Stivarga (regorafenib) to Treat Hepatocellular Carcinoma
Feb 25, 2013Approval FDA Approves Stivarga for Advanced Gastrointestinal Stromal Tumors
Sep 27, 2012Approval FDA Approves Stivarga for Advanced Colorectal Cancer
Aug 30, 2012Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST)
Jun 28, 2012U.S. FDA Grants Priority Review to the New Drug Application for Bayer's Regorafenib to Treat Patients with Metastatic Colorectal Cancer
May 23, 2012Bayer Submits New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer

Further information

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