Bayer-Onyx Thyroid Cancer Drug Approved By EC
Onyx Pharmaceuticals, which is a subsidiary of Amgen, and Bayer HealthCare have announced that the European Commission has granted marketing authorization for the companies’ Nexavar drug. Nexavar, or sorafenib, is an oral multi-kinase inhibitor that treats patients with progressive, locally advanced, or metastatic differentiated thyroid carcinoma.
The development of Nexavar has proceeded as planned, as the drug had previously been granted an orphan drug designation in the EU. Dr. Joerg Moeller, a member of the Bayer HealthCare executive committee and head of global development, says this marketing authorization will extend the drug’s scope to a larger group of patients. “Differentiated thyroid cancer is a rare but serious disease, with patients who were lacking new treatment options for over forty years,” said Moeller. “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.”
Nexavar’s approval was based on the results of its Phase III DECISION trial, which studied the effects of sorafenib on locally advanced or metastatic radioactive iodine refractory thyroid cancer patients. The trial was an international placebo-controlled study that had enrolled 417 patients. Patients who had been treated with Nexavar rather than the placebo saw a 41 percent reduction in the risk of disease progression or death. Common side effects of Nexavar use included hand-foot skin reactions, alopecia, diarrhea, fatigue, weight loss, and hypertension. Bayer and Onyx have also stated that Nexavar is being studied for its potential uses on a variety of different cancers.
Thyroid cancer is the most common endocrine cancer, and there are almost 300,000 new cases worldwide each year. Each year, 40,000 people die from thyroid cancer. Differentiated thyroid cancer, which Nexavar treats, accounts for about 94 percent of all thyroid cancer. RAI-refractory locally advanced or metastatic disease is the most difficult form of thyroid cancer to treat, and it has the lowest survival rates.