Official announcement from the Chinese regulatory authority

FDA Approves Novocure's Optune Lua for Metastatic NSCLC with PD-1/PD-L1 Inhibitors, Based on LUNAR Study

Oct 15, 2024, 08:09 PM

The FDA has approved Novocure's Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel in treating metastatic non-small cell lung cancer (mNSCLC) for patients who have progressed on or after a platinum-based regimen. This approval, announced on October 15, is based on the LUNAR study, which demonstrated a statistically significant improvement in overall survival (OS). Additionally, sunvozertinib has received Breakthrough Therapy Designation in China for treatment-naive EGFR Exon 20+ non-small cell lung cancer (NSCLC) as of October 14. Furthermore, the FDA has approved durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable NSCLC.