European Commission Approves Bayer’s Thyroid Cancer Drug Nexavar

May 30, 2014

The European Commission has given Bayer HealthCare and Onyx Pharmaceuticals approval to market Nexavar (sorafenib) for the treatment of differentiated thyroid cancer (DTC), the company said.

The drug is indicated for patients with progressive, locally advanced or metastatic thyroid cancer. It already is approved for advanced kidney and liver cancers. While most conventional chemotherapy is administered intravenously, Nexavar, an oral multi-kinase inhibitor, is administered in pill form, according to the Angiogenesis Foundation.

“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,” said Dr. Joerg Moeller, a member of the Bayer HealthCare executive committee and head of global development.

The approval comes after impressive data from a phase III clinical trial that found sorafenib vastly extended progression-free survival (PFS) compared with a placebo. Patients receiving sorafenib had a 41 percent reduction in the risk of disease progression or death compared with patients being treated with the placebo, Bayer said May 30. — Harry Morrison

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