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.
The safety and tolerability profile of sorafenib in patients in the trial was generally consistent with the known profile of sorafenib. The most common treatment-emergent adverse events in the sorafenib arm were hand-foot skin reaction, diarrhea, alopecia, weight loss, fatigue, hypertension and rash.
Results from the trial were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2013 and published in The Lancet in April 2014.