Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer
Shots:
- Approval was based on the P-III (PANOVA-3) trial assessing Optune Pax, a TTFields device used concomitantly with gemcitabine & nab-paclitaxel (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer
- Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In mPP (198 received Optune Pax + CT for ≥28 days vs 207 received ≥1 CT cycle), mOS was 18.3 vs 15.1mos., with 1yr. survival of 75.2% vs 65.9%
- Optune Pax + CT extended median time to pain progression to 15.2 vs 9.1mos.; QoL (EORTC QLQ-C30/PAN26) showed longer DFS in global health, pain, pancreatic pain, digestive issues, with similar trends in emotional function & fatigue, while other 2EPs showed no significant difference
Ref: Businesswire | Image: Novocure |Press Release
Related News: Novocure Reports Final P-III (METIS) Trial Data on Tumor Treating Fields (TTFields) Therapy for Brain Metastases from NSCLC
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