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Novocure has obtained CE Mark approval for its Optune Lua device to treat adults with metastatic non-small cell lung cancer (NSCLC) simultaneously with immune checkpoint inhibitors or docetaxel.
This offers a new option for those who have advanced on or post a platinum-based chemotherapy.
The portable device generates Tumor Treating Fields (TTFields), the alternating electric fields that are released through wearable, non-invasive arrays.
These fields apply physical force to the charged components of proliferating cancer cells, leading to their death.
The CE Mark enables the company to commence local registration requirements in Germany, with plans to launch Optune Lua soon.
It comes after the US Food and Drug Administration’s (FDA) approval in October 2024.
The Phase III LUNAR trial's data, assessing the device’s treatment efficacy and safety when used simultaneously with immune checkpoint inhibitors or docetaxel, supported the latest CE Mark approval.
Subjects in the trial treated with the device alongside an immune checkpoint inhibitor or docetaxel experienced a median overall survival (OS) of 13.2 months.
Novocure oncology president Frank Leonard said: “The CE Mark approval for Optune Lua for metastatic non-small cell lung cancer is a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers.
“TTFields therapy has demonstrated effectiveness in multiple tumour types that have historically been very difficult to treat, including lung cancer.”
As part of the conditions for the CE Mark receipt, the company will carry out a post-market trial to further evaluate TTFields in combination with docetaxel, aiming to include 180 subjects with a follow-up period of 12 months, and will evaluate OS in a routine care setting.
This study will provide outcomes to compare against a matched control group receiving only docetaxel treatment.
In March 2024, the company’s TTFields therapy met its primary endpoint in the Phase III METIS study, demonstrating the progression of brain metastasis in individuals with NSCLC.
"Novocure’s device for metastatic NSCLC treatment gains CE Mark" was originally created and published by Medical Device Network, a GlobalData owned brand.
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