A WEARABLE medical device for advanced lung cancer has now been granted approval by the U.S. FDA. The device is used to treat metastatic non-small cell lung cancer (mNSCLC) in adult patients used alongside PD-1/PD-L1 inhibitors or docetaxel when cancer has progressed despite the use of platinum-based chemotherapy.
Approval was granted following the Phase III LUNAR trial, which enrolled 291 patients with metastatic NSCLC who had progressed during or after platinum-based treatments. The study demonstrated that patients who received Optune Lua (NovoCure Limited, Jersey, UK) in combination with a PD-1/PD-L1 inhibitor or docetaxel had a median overall survival of 13.2 months, compared to 9.9 months in the control group receiving standard treatment.
Optune Lua uses a technology that delivers electrical fields via arrays placed on the patient’s skin, known as Tumor Treating Fields. According to the medical device company, these fields target dividing cancer cells, interfering with growth and resulting in cell death. This non-invasive method does not introduce systemic toxicity, which supports effective side effect management often associated with traditional therapies.
Ticiana Leal, Emory University School of Medicine, Atlanta, Georgia, was a lead investigator on the LUNAR study, and highlighted that the trial results represent the first significant improvement in overall survival for this patient population in over 8 years. This new approval offers an option for patients with advanced lung cancer who have limited choices following standard therapies.
The Tumor Treating Fields technology is also being investigated in other metastatic conditions, including brain metastases in patients with non-small cell lung cancer, where early trials have shown results in slowing disease progression.
Reference: Medical Device Network. NovoCure scoops FDA approval on wearable for metastatic cancer treatment. October 17, 2024. Available at: https://www.medicaldevice-network.com/news/novocure-scoops-fda-approval-on-wearable-for-metastatic-cancer-treatment/?cf-closed. Last accessed: October 17, 2024.
Anaya Malik | AMJ
