FDA Approves Stivarga (regorafenib) for GIST

On February 25, 2013 the FDA approved regorafenib (brand name Stivarga) for treatment of GIST patients with “advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease” (Gleevec and Sutent). This makes regorafenib the first drug approved for third-line treatment of GIST.

Regorafenib is also approved for GIST in Japan, Chile, Ecuador, the EU, Uruguay, and Venezuela.

LINK HERE for a pdf news release from Bayer about the basis for the filing in positive results for regorafenib against GIST in the GRID trial.

For more about regorafenib, see our GSI webpage about this drug.