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Bayer’s Orphan Drug Stivarga Receives A Second FDA Indication

February 26, 2013

On February 25, 2013, Bayer and Onyx Pharmaceuticals announces that the US FDA approves orphan drug Stivarga (Regorafenib) tablets for the treatment of patients with locally advanced, unresectable or metastatic Gastrointestinal Stromal Tumors (GIST), who have previously been treated with orphan drug Gleevec (Imatinib) and Sutent (Sunitinib). Sutent and Gleevec are the two other FDA-approved drugs for GIST. The approval is granted 3 days before the scheduled PDUFA date of February 28. This is the second indication for Stivarga which receives FDA approval in September 2012 for patients with Metastatic Colorectal Cancer (mCRC).

Stivarga is developed by Bayer and jointly promoted by Bayer and Onyx Pharmaceuticals in the US. Both companies enter into an agreement in 2011, where Onyx Pharmaceuticals receives a royalty on all global net sales of Stivarga in oncology.

The approval of Stivarga for GIST is based on pivotal Phase III GRID clinical trial data. The data shows that Stivarga and Best Supportive Care (BSC)  significantly improved Progression-Free Survival (PFS) compared to placebo and BSC in patients with locally advanced, unresectable or metastatic GIST previously treated with Gleevec and Sutent. Median PFS is 4.8 months in the Stivarga arm verses 0.9 months in the placebo arm.

GIST Facts

–  Is a tumor in which cancerous cells form in tissues of the gastrointestinal tract

–  In the US, an estimated 4,000 – 5,000 new cases is diagnosed each year, with approximately 1,500 patients having metastasis at diagnosis.

Stivarga Facts

– A multi-kinase inhibitor that blocks enzymes that promote cancer growth

– Intended for GIST patients who cannot have it removed by surgery, or where it has metastasized  and no longer responds to Gleevec & Sutent

– Receives FDA Orphan Drug Designation (ODD) in January 2011 for GIST

– Developed under the FDA Fast Track program which expedites development and review of drugs to treat serious diseases

– Receives FDA Priority Review Designation for GIST and mCRC.


FDA February 25, 2013 Press Release.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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