FDA approves Stivarga (Bayer HealthCare) in patients with GIST
The FDA has approved Stivarga (regorafenib), from Bayer HealthCare, to treat patients with locally advanced, unresectable or metastatic Gastrointestinal Stromal Tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Approval is based on data from the pivotal Phase III GRID trial, which showed that Stivarga plus best supportive care (BSC) statistically significantly improved progression-free survival (PFS) compared to placebo plus BSC (p<0.0001) in patients with locally advanced unresectable or metastatic gist who have been previously treated with imatinib mesylate and sunitinib malate.>
The median PFS was 4.8 months in the Stivarga arm versus 0.9 months in the placebo arm (p<0.0001). there was no statistically significant difference in overall survival at the time of the planned interim analysis based on 29 of the total events for the final analysis.>
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.