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Novocure's Optune Lua® Receives Approval in Japan for the Treatment of Non-Small Cell Lung Cancer

Novocure (NVCR) | September 15, 2025

By Ian Walker

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Novocure's Optune Lua® has received approval in Japan for the treatment of unresectable advanced/recurrent non-small cell lung cancer (NSCLC).

The approval allows concurrent use of Optune Lua with PD-1/PD-L1 inhibitors for adult patients who have progressed on or after platinum-based chemotherapy.

The Ministry of Health, Labour and Welfare approval is based on the results of the Phase 3 LUNAR trial, showing significant improvement in median overall survival in NSCLC patients treated with Optune Lua.

Ministry Approval in Japan

Optune Lua approved for use with PD-1/PD-L1 inhibitors in adult NSCLC patients post platinum-based chemotherapy.

Phase 3 LUNAR Trial Results

Statistically significant improvement in median overall survival rates with Optune Lua treatment.

Device Description

Optune Lua is a wearable medical device delivering Tumor Treating Fields for cancer cell death.

  • The approval opens up a new treatment option for advanced NSCLC patients in Japan.
  • Patients treated with Optune Lua concurrently with PD-1/PD-L1 inhibitors showed a 3.3-month extension in median overall survival compared to the control group.
  • Device-related adverse events were mostly low grade, indicating a manageable safety profile for Optune Lua.

The approval of Optune Lua in Japan marks a significant milestone in the treatment of NSCLC, offering hope to patients facing this aggressive disease. Novocure's focus on innovative therapies continues to make a positive impact on cancer treatment worldwide.