Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, announced that the European Commission (EC) has granted marketing authorization for the oral multi-kinase inhibitor Nexavar (sorafenib) for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Nexavar was previously granted orphan drug designations for the treatment of follicular and papillary thyroid cancer in the EU.

 

“Differentiated thyroid cancer is a rare but serious disease, with patients who were lacking new treatment options for over forty years,” said Dr. Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development. “The approval in DTC marks Nexavar’s third indication in Europe, and we are proud to extend this proven treatment option to even more people in need.”

 

The approval is based on data from the Phase 3 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 (p<0.001), which represents a 41% 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.

 

Date: May 30, 2014

Source: Bayer HealthCare