Novocure's Optune Lua receives CE Mark for metastatic NSCLC treatment

NovoCure Ltd

CE Mark for Optune Lua in mNSCLC with immune checkpoint inhibitors or docetaxel after platinum progression.
Phase 3 LUNAR trial: median OS 13.2 months (Optune Lua) vs 9.9 months (control); primary endpoint met.
Subgroup with immune checkpoint inhibitor: median OS 18.5 vs 10.8 months (P=0.03).
Local registration initiated in Germany; launch expected in coming weeks. FDA approval received Oct 2024.
Post-market study of TTFields with docetaxel required as condition; 180 patients, 12-month follow-up.

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