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# Novocure’s Optune Lua for Lung Cancer OK’d
- URL: https://www.fdaweb.com/novocures-optune-lua-for-lung-cancer-okd/
- Published: 2024-10-16T12:00:00.000Z
- Updated: 2026-09-14T14:44:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157995

FDA has approved a Novocure PMA for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. The portable device is designed to produce alternating electric fields (tumor treating fields (TTFields)), which are delivered through wearable arrays, according to the company. “TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death,” it says.

Approval is based on data from the Phase 3 LUNAR study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel (experimental arm) to PD-1/PD-L1 inhibitors or docetaxel alone. The primary endpoint was met and demonstrated a “statistically significant and clinically meaningful 3.3-month (P=0.04) extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n=145),” Novocure says.

The study also had two secondary endpoints. The first met statistical significance, according to the company, assessing median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint did not meet statistical significance, it says.

On the safety side, the company says device-related adverse events occurred in 63.1% of patients (n=89), with most being skin-related disorders under the transducer arrays.