regulatory
confidence high
sentiment positive
materiality 0.70
FDA accepts Novocure's PMA for TTFields in NSCLC post-platinum; decision H2 2024
NovoCure Ltd
- PMA application accepted for filing; FDA begins substantive review.
- Submission filed Dec 15, 2023; regulatory decision expected in second half 2024.
- TTFields therapy plus standard systemic therapies for NSCLC after progression on platinum-based therapy.
- CEO states milestone brings therapy closer to patients with few non-toxic options.
- Application based on LUNAR trial data in post-platinum NSCLC.