Bayer Inc. is pleased to announce the Health Canada approval of Nexavar for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

The approval is based on data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial. In the trial, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo (HR=0.59 [95% CI, 0.45-0.76]; p<0.0001), which represents a 41 percent reduction in the risk of disease progression or death for patients who received sorafenib compared to placebo-treated patients. The median PFS was 10.8 months in patients treated with sorafenib, compared to 5.8 months in patients receiving placebo.

For more details, go to: http://www.bayer.ca/files/NOC%20press%20release_FINAL.pdf