Novocure has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of its portable鈥疧ptune Lua device alongside PD-1/PD-L1 inhibitors to treat non-small cell lung cancer (NSCLC).
The device is indicated for adults with unresectable advanced/recurrent NSCLC who have progressed on or following platinum-based chemotherapy.
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Optune Lua is a wearable device that works by delivering alternating electric fields, also known as tumour treating fields (TTFields), via non-invasive wearable arrays.
The TTFields target dividing cancer cells, leading to cell death while minimally affecting healthy cells due to their distinct properties.
According to Novocure, they can be used with other cancer treatments such as chemotherapy and radiotherapy, to address challenges across various solid tumours.聽
Novocure president Frank Leonard said: 鈥淟ung cancer is the leading cause of cancer-related death worldwide, and unfortunately, in Japan, the number of cases continues to increase, which is why we see an urgent need for innovative treatment options for this disease.聽
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By GlobalData鈥淣ovocure is focused on launching Optune Lua as quickly as possible in Japan so that patients with non-small cell lung cancer experiencing a progression after initial platinum-based treatment have access to our therapy.鈥�
The MHLW approval is based on results from the Phase III LUNAR trial, in which Optune Lua showed a significant improvement in median overall survival (OS).
The open-label, randomised, multicentre study assessed the device with PD-1/PD-L1 inhibitors or docetaxel compared to the inhibitors or docetaxel alone (control group).
Device-related adverse events were mainly skin-related and mostly low grade, with no severe toxicities causing death recorded.
In November 2024, Novocure secured the US Food and Drug Administration (FDA) clearance for use of its head flexible electrode (HFE) transducer arrays with Optune Gio, a wearable intended for treating adults with glioblastoma (brain cancer).
