Bayer/Onyx file Nexavar at FDA and EMA for treatment of Thyroid Cancer
Bayer HealthCare and Onyx Pharmaceuticals have announced the submission of a supplemental New Drug Application or sNDA to the FDA for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated Thyroid Cancer.
An application has also been made for marketing authorization to the European Medicines Agency or EMA.
The regulatory submission 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, an international, multicenter, placebo-controlled study.In the trial, sorafenib significantly extended progression-free survival, the primary endpoint of the study, compared to placebo.
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