Novocure Gains FDA Approval for Optune Pax to Treat Pancreatic Cancer

Core Viewpoint - Novocure (NVCR) has received FDA approval for its portable therapeutic device, Optune Pax, for treating adult patients with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel, ahead of the expected timeline of Q2 2026 [1][2] Company Developments - The FDA approval is based on the successful phase III study, PANOVA-3, which showed that Optune Pax combined with gem/nab-pac significantly improved overall survival compared to gem/nab-pac alone [2][9] - Novocure has other commercialized therapies using Tumor Treating Fields (TTFields), including Optune Gio for glioblastoma multiforme and Optune Lua for metastatic non-small cell lung cancer [3] - The company is also developing therapies for treating metastatic pancreatic cancer and newly diagnosed glioblastoma multiforme [3] Clinical Data - The PANOVA-3 study demonstrated a median overall survival (mOS) of 16.2 months for patients treated with Optune Pax and gem/nab-pac, compared to 14.2 months for those receiving gem/nab-pac alone [8][10] - The one-year survival rate was 68.1% for the Optune Pax group versus 60.2% for the gem/nab-pac group [10] - Additionally, the median time to pain progression improved to 15.2 months with Optune Pax compared to 9.1 months for gem/nab-pac alone [10] Market Potential - The pancreatic cancer market is projected to grow from $3.01 billion to $9.57 billion between 2025 and 2034, at a CAGR of 13.7%, driven by increasing cases and advancements in treatment options [12] - The approval of Optune Pax is expected to enhance Novocure's market prospects, given the limited treatment options currently available for pancreatic cancer [12] Financial Performance - Novocure reported preliminary net revenues of $174.4 million for Q4 and full-year 2025, reflecting an 8% year-over-year increase, with total revenues for the year reaching $655 million [13]