Thyroid cancer has become one of the fastest-increasing cancers in recent years and is the fifth most common cancer in women. There are more than 213,000 new cases of thyroid cancer annually and approximately 35,000 people die from thyroid cancer worldwide each year. The U.S. Food and Drug Administration (FDA) has approved the oral multi-kinase inhibitor sorafenib (NEXAVAR®) for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. This type of thyroid cancer has previously been difficult to treat and some patients are unresponsive to standard therapy.
Sorafenib is now the first FDA-approved agent for this condition and offers new options for patients who have been limited in their treatment outcomes. Sorafenib is an antiangiogenic drug already approved for renal cell carcinoma and hepatocellular carcinoma.
Sorafenib’s approval is based on the results of the randomized DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study involving 417 patients. Patients who received 400 mg oral sorafenib twice daily lived on average nearly 11 months longer without progression of their disease compared to those who did not receive treatment.