Bayer and Onyx’s Nexavar Receives European Regulatory Approval for Thyroid Cancer
The European Commission have given marketing authorisation to use Nexavar, oral multi-kinase inhibitor, to treat the most common form of thyroid cancer, expanding the approved uses for the drug.
Nexavar, which has previously received regulatory approval for advanced kidney and liver cancers, has now been approved for the treatment of metastatic differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
The approval was based on results from a phase III clinical trial which showed that the oral multi-kinase inhibitor extended progression-free survival by 41% in comparison to placebo (10.8 months versus 5.8 months).
Joerg Moeller, head of global development at Bayer HealthCare, commented that DTC is a rare but serious disease, “with patients who were lacking new treatment options for over forty years.”
Bayer noted that there are over 298,000 new cases of thyroid cancer yearly and almost 40,000 people die from the disease globally each year.
Nexavar was approved for the thyroid cancer indication by the US FDA in November 2013.