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news.Bayer HealthCare and Onyx Pharmaceuticals are seeking approval for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets to treat locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer in the US and Europe.
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A supplemental New Drug Application (sNDA) was submitted to FDA and an application for marketing authorization to the European Medicines Agency (EMA) for Nexavar.
Bayer HealthCare executive committee member and global development head Kemal Malik said, "The filings in the U.S. and Europe for sorafenib for the potential treatment of this type of thyroid cancer bring us closer to addressing an unmet medical need for these patients who have limited or no treatment options."
The data from the Phase 3 study of sorafenib in locally advanced or metastatIc patients with radioactive Iodine refractory thyroid cancer (DECISION) trial support the regulatory filings.
Sorafenib significantly extended progression-free survival (PFS) compared to placebo, reaching the primary endpoint of the study.
Onyx Pharmaceuticals global research and development and technical operations Pablo Cagnoni said, "Based on results from clinical studies we believe sorafenib could potentially provide a new option for the treatment of differentiated thyroid cancer that no longer responds to radioactive iodine therapy."