EU approval for Nexavar for treatment of Thyroid Cancer - Bayer Healthcare
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/H�rthle 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.
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, 0.46-0.76]; p<0.001), 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.>
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