A New Regorafenib FDA Approval for GIST Patients


FDA Approved February 2013 Regorafenib CAS 755037-03-7Bayer announced the Regorafenib FDA Approval on February 25, 2013. Known as the brand name Stivarga, Regorafenib is specifically for patients with gastrointestinal stromal tumor (GIST) that is unresectable.  Regorafenib is a last option treatment for patients with GIST who have metastatic cancer that is unresponsive to first line treatments approved by the FDA, like imatinib (Gleevac) and sunitinib (Sutent).  This new indication for regorafenib (Stivarga) for patients with GIST is based on data from a phase lll trial coined GRID, or  GIST – Regorafenib In Progressive Disease. Patients in this important trial demonstrated an improved progression-free survival  when taking regorafenib as compared to those patients who received a placebo. All patients enrolled in the study, whether they received regorafenib or a placebo received best supportive care, or BSC, as well. For clinical trial participants who were administered regorafenib (Stivarga) the median progression free survival was 4.8 months,  versus 0.9 months in the placebo group.  Risks of this formidable treatment include hepatoxicity, infection and a host of other adverse effects. However, the risks of taking regorafenib cannot be matched by the benefit of extended life for patients.

vascular endothelial growth factor receptors Regorafenib was previously approved by the FDA on  May 23, 2012 to treat patients with metastatic colorectal cancer. As a powerful treatment with both antiangiogenic and antineoplastic activity, regorafenib is unique in that it binds to and inhibits the vascular endothelial growth factor receptors 2 and 3, as well as Raf kinases. The novel ability of regorafenib to inhibit tumor angiogenesis and tumor cell proliferation makes this new FDA indication and approval for patients with GIST not surprising. The initial approval of regorafenib for unresectable colon cancer was based on the Phase III CORRECT trial, which was completed by Bayer. The CORRECT study was an international, randomized, double-blind, and placebo-controlled trial which consisted of 760 participants. All of the clinical trial participants  had unresectable, metastatic colorectal cancer that had progressed despite standard therapies within three months of time.  The patients received either regorafenib plus supportive care or a placebo plus supportive care. The treatment cycles consisted of 160 mg of regorafenib, or a matching placebo, once daily for three weeks in a row, and one week off.  Survival rates improved for 29 percent of the patients who received regorafenib, and there was a median overall survival of 6.4 months, as compared to a 5 month survival for patients who received the placebo.

Regorafenib has proven to be crucial for the treatment of both metastatic colorectal cancer and unresectable  gastrointestinal stromal tumor. LGM Pharma offers API Regorafenib for research and development purposes. Clients can be assured of quality products and continuous support throughout the R&D process.

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