The FDA granted priority review designation to a marketing application seeking approval of Bayer and Onyx Pharmaceuticals' Nexavar (sorafenib) for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer, the companies said Tuesday. The agency is scheduled to make a decision on the submission by December 25.
Bayer and Onyx noted that the filing is based on data from the DECISION trial, which included 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer. Results, which were presented at the ASCO annual meeting earlier this year, showed that Nexavar extended progression-free survival by 42 percent compared to placebo.
Nexavar is already approved in the US for the treatment of patients with unresectable hepatocellular carcinoma and for those with advanced renal cell carcinoma. The oral multi-kinase inhibitor is currently approved in more than 100 countries.
Earlier this week, Onyx agreed to be acquired by Amgen for $125 per share, or approximately $10.4 billion, with the latter gaining rights to Onyx's Nexavar and a number of other cancer drugs including Kyprolis (carfilzomib) and Stivarga (regorafenib).