Optune Lua
FDA premarket approval P230042 · decided 2024-10-15
Approval details
- PMA number
- P230042
- Trade name
- Optune Lua
- Generic name
- Electrical tumor treatment fields for non-small cell lung cancer
- Applicant
- Novocure, GmbH
- Date received
- 2023-12-15
- Decision date
- 2024-10-15
- Days to decision
- 305 days
- Decision code
- APPR
- Product code
- SDA
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Baar
- Statement
- Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.
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