Biotech Exelixis Inc. (NASDAQ:EXEL) saw its shares surge in premarket trade on Monday after the U.S. Food and Drug Administration granted priority review status for its supplemental New Drug Application (sNDA) for the treatment for advanced renal cell carcinoma (RCC).
In a statement, the company said the sNDA is based on results from a mid-stage trial of Cabometyx, and is aimed at patients with previously untreated advanced RCC.
If the biotech wins FDA approval, it will be able to make changes to the product label, including modifications to the indication.
Cabometyx was given the green light by the FDA in April of 2016 for the treatment of patients with advanced RCC who have received prior anti-angioegenic therapy, or drugs that stop tumors from growing their own blood vessels.
Kidney cancer is one of the top 10 most common forms of cancer in the U.S., the company said.
In premarket trade, its shares surged 23.63% at US$30.61.