SUMMARY: STIVARGA® (Regorafenib) is an oral multikinase inhibitor. In this international trial, 199 patients with advanced GIST who had progressed on both GLEEVEC® (Imatinib) and SUTENT® (Sunitinib) were randomized in a 2:1 ratio to receive either STIVARGA® or placebo. The primary endpoint was progression-free survival (PFS). Patients in the STIVARGA® group had a statistically significant 3.9 month improvement in progression-free survival (PFS) compared to placebo (4.8 months vs 0.9 months; Hazard Ratio = 0.27; P<.0001). Following progression, 85% of the patients assigned to the placebo group crossed over to the STIVARGA® group. Treatment was well tolerated and the most common adverse events included hypertension, hand-foot syndrome and diarrhea. There is now a new treatment option for patients with GIST who progress on GLEEVEC® and SUTENT®. Demetri GD, Reichardt P, Kang Y, et al. The Lancet. 2013;381:295-302
Month: March 2013
STIVARGA® (Regorafenib)
The FDA on February 25, 2013 approved the use of STIVARGA® for the treatment of patients with advanced GastroIntestinal Stromal Tumors (GIST) that are unresectable or metastatic and are no longer responding to GLEEVEC® (Imatinib) and SUTENT® (Sunitinib). The FDA initially approved STIVARGA® in 2012 for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, ELOXATIN® (Oxaliplatin), and CAMPTOSAR® (Irinotecan) based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. STIVARGA® is a product of Bayer HealthCare Pharmaceuticals, Inc.
STIVARGA® (Regorafenib) for advanced GIST
STIVARGA® is an oral multikinase inhibitor. In a study published in the January 2013 issue of THE LANCET, treatment with STIRVAGA® in patient population resistant or refractory to GLEEVEC® and SUTENT® resulted in significant improvement in progression free survival. This is the third agent approved by the FDA for advanced GIST. As patients with advanced GIST live longer, newer agents with unique mechanism of action will take center stage.