The European Commission has expanded the approved uses of Bayer and Amgen unit Onyx Pharmaceuticals' Nexavar to treat the most common form of thyroid cancer.
Specifically, Nexavar (sorafenib), which is already approved for advanced kidney and liver cancers, has got the green light for the treatment of metastatic differentiated thyroid carcinoma that is refractory to radioactive iodine treatment. The thumbs-up is based on data from a trial which showed that the oral multi-kinase inhibitor extended progression-free survival by 41% compared to placebo (10.8 months versus 5.8 months).
Joerg Moeller, head of global development at Bayer HealthCare, noted that DTC is a rare but serious disease, “with patients who were lacking new treatment options for over forty years”. The approval marks Nexavar’s third indication in Europe, he noted, “and we are proud to extend this proven treatment option to even more people in need”.
The drug was approved for the thyroid cancer indication by the US Food and Drug Adminisdtration in November last year. Bayer noted that there are more than 298,000 new cases of thyroid cancer annually and nearly 40,000 people die from the disease worldwide each year.