Bayer HealthCare and Onyx announced that the FDA has granted Priority Review to their supplemental New Drug Application (sNDA) for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets in the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis.
The submission was based on the DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patients with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study. A total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer were randomized to receive 400mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients). Ninety-six percent of randomized patients had metastatic disease. The primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
Nexavar is already approved for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.
For more information call (866) NEXAVAR or visit www.nexavar-us.com.