EC approves Bayer's Nexavar for differentiated thyroid cancer

German drug major Bayer (BAYN: DE) and Onyx Pharmaceuticals, now a subsidiary of US biotech firm Amgen (Nasdaq: AMGN), have received marketing authorization from the European Commission for the oral multi-kinase inhibitor Nexavar (sorafenib) for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hurthle 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 European Union and was  recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for this indication last month.

“Differentiated thyroid cancer is a rare but serious disease, with patients who were lacking new treatment options for over 40 years,” said Joerg Moeller, a 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,” he added.

Nexavar, which generated sales of 771 million euros ($1.07 billion) in 2013, was first authorized in the EU in July 2006. It is currently approved to treat patients who have hepatocellular carcinoma, or advanced renal-cell carcinoma.