Novocure's Optune Lua Receives Approval for Advanced Lung Cancer Treatment in Japan

Novocure's Optune Lua has received approval in Japan for treating unresectable advanced/recurrent non-small cell lung cancer. Optune Lua is a wearable device that produces alternating electric fields to kill cancer cells. It can be used concurrently with PD-1/PD-L1 inhibitors for patients who have progressed on platinum-based chemotherapy. This approval expands the potential uses of TTFields therapy, which can be combined with various cancer treatment modalities.

September 12, 2025 — Novocure (NASDAQ: NVCR) announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy Novocure's Optune Lua® Receives Approval in Japan for the Treatment of Unresectable Advanced/Recurrent Non-Small Cell Lung Cancer^[1].

Optune Lua is a wearable, portable medical device that produces alternating electric fields known as Tumor Treating Fields (TTFields). These fields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cancer cell death. The approval expands the potential uses of TTFields therapy, which can be combined with various cancer treatment modalities Novocure's Optune Lua® Receives Approval in Japan for ...^[2].

The MHLW approval is supported by the results of the pivotal Phase 3 LUNAR trial, which demonstrated a statistically significant and clinically meaningful improvement in median overall survival (OS) for patients treated with Optune Lua concurrently with PD-1/PD-L1 inhibitors or docetaxel compared to PD-1/PD-L1 inhibitors or docetaxel alone Novocure's Optune Lua® Receives Approval in Japan for ...^[2]. The trial showed a 3.3-month extension in median OS for patients treated with Optune Lua, with a median OS of 13.2 months compared to 9.9 months in the control group.

Dr. Tetsuya Mitsudomi, President of Izumi City General Hospital, commented, "With the Ministry of Health, Labour and Welfare approval granted to Optune Lua, we now have a new treatment option available to patients with advanced non-small cell lung cancer." Frank Leonard, President of Novocure, added, "Lung cancer is the leading cause of cancer-related death worldwide, and unfortunately, in Japan the number of cases continue to increase, which is why we see an urgent need for innovative treatment options for this disease."

Novocure's Optune Lua is a significant addition to the treatment landscape for NSCLC, offering a new approach to cancer treatment that can be combined with other therapies. The approval in Japan expands the potential patient population and market for Optune Lua, positioning it as a promising tool in the ongoing fight against lung cancer.