FDA approval of Optune Lua follows the Phase 3 LUNAR trial, showing significant improvement in median overall survival for metastatic NSCLC patients.
Lung cancer patients have reason for new hope. The U.S. Food and Drug Administration has approved Novocure’s Optune Lua for use alongside PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic non-small cell lung cancer. This approval offers hope to patients who have progressed after platinum-based chemotherapy.
What is it?
Optune Lua is a portable, wearable device that delivers Tumor Treating Fields, a therapy that uses electric fields to disrupt cancer cell division. By applying these physical forces to the electrically charged components of dividing cancer cells, the treatment causes cell death, offering an alternative option without systemic toxicity.
“This approval represents a major advancement for those battling metastatic NSCLC,” said Asaf Danziger, CEO of Novocure, in a statement. “For patients who have few remaining options after chemotherapy, Optune Lua offers new possibilities for extending survival.”
Improved survival rates
The approval follows the Phase 3 LUNAR trial, which demonstrated a substantial improvement in median overall survival—the first of its kind in over eight years for this patient population. Ticiana Leal, M.D., the study’s primary investigator and Director of the Thoracic Oncology Program at Emory University, said: “Patients with advanced NSCLC often face limited treatment options after first-line therapies fail. The results from the LUNAR trial mark a breakthrough in survival rates, which, when paired with the non-toxic nature of Optune Lua, provide a compelling option for physicians and patients.”
What this means for doctors
With the approval of Optune Lua, oncologists now have an innovative tool in their arsenal to help improve outcomes for patients with advanced lung cancer. Unlike traditional treatments, which can cause significant side effects, Optune Lua’s non-invasive nature makes it an appealing choice for those patients who have already endured aggressive therapies.
Danielle Hicks, Chief Patient Officer for GO2 for Lung Cancer, said: “We’re excited to see more treatment choices for those with metastatic NSCLC. This approval brings new hope to patients and their families who urgently need more effective treatments.”