Shares of NovoCure Ltd. (NVCR) skyrocketed over 30% in pre-market trading on Tuesday, following the U.S. Food and Drug Administration's (FDA) approval of its Optune Lua device for the treatment of metastatic non-small cell lung cancer (NSCLC).

The FDA approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen. This approval marks a significant milestone, as the results of the pivotal LUNAR trial represent the first substantial improvement in median overall survival in more than eight years for this patient population.

Optune Lua is a wearable, portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields). These TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death. The approval expands the potential market for NovoCure's innovative therapy and is seen as a breakthrough for patients with limited treatment options in advanced lung cancer.