regulatory
confidence high
sentiment positive
materiality 0.75
Japan MHLW approves Novocure's Optune Lua for advanced NSCLC
NovoCure Ltd
- Japan MHLW approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors in advanced/recurrent NSCLC after platinum-based chemo.
- Approval based on Phase 3 LUNAR trial: median OS 13.2 vs 9.9 months (3.3-month improvement, p=0.04).
- In PD-1/PD-L1 subgroup, median OS 19.0 vs 10.8 months (8.2-month improvement, p=0.02).
- Optune Lua is a wearable TTFields device; device-related AEs were mostly grade 1-2 skin reactions.
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