U.S. based FDA has approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors for treatment of patients with metastatic non-small cell lung cancer and whose disease has progressed on or after platinum-based regimen. This approval is based on the LUNAR Phase 3 study. The patients with Optune Lua realized a notable improvement in overall conditions in comparison to patients with standard therapy only. Optune Lua is a wearable device for which tumor-treating fields inhibit proliferation and metastasis of lung cancer cells. In this method, it utilizes low intensity and different frequencies. This approval by FDA has opened up the potential of this treatment for NSCLC patients.
This wearable treatment delivers Tumor Treating Fields which exert physical forces on the electrically charged components of dividing cancer cells and this results in cell death.
Novocure is committed to extending survival in some of the most aggressive and difficult to treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” said Asaf Danziger, CEO, Novocure. “We are grateful to the patients, caregivers, investigators and healthcare providers who supported the clinical trials that led to this approval.”
The results of the study showed a statistically significant improvement in OS with addition of concurrent Optune Lua. It met a prespecified secondary endpoint showing addition of Optun3 Lua to PD-1/PD-L1 inhibitor therapy conferred significant improvement in OS. The overall survival rates observed with Optune Lua in LUNAR study mark the first substantial improvement in over eight years in this patient population, making it a compelling development for many patients.
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