The US Food & Drug Administration (FDA) has cleared Novocure’s Optune Pax device for locally advanced pancreatic cancer treatment, representing the first clearance by the agency in this indication since Eli Lilly’s Gemzar (gemcitabine) chemotherapy drug in 1996.
Indicated for concomitant use alongside gemcitabine and nab-paclitaxel, Optune Pax delivers tumour treating electric fields (TTFields) via arrays worn on the abdomen. These target the electrical properties of cancer cells to disrupt processes critical for cancer cell division and survival. The portable device’s approach is intended to result in cell death without significantly affecting healthy cells, sharing a similar strategy to targeted cancer drugs.
Novocure’s shares on the Nasdaq stock exchange climbed by around 37% to a market open of $14.40 on 12 February following news of the FDA approval, representing an uptick from $10.50 previously. Novocure has a market cap of $1.4bn.
Novocure CEO Frank Leonard commented: “The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer.
“Systemic therapies have shown poor bioavailability in pancreatic tumours, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilising a biophysical approach that targets the unique electrical properties of cancer cells.”
Optune Pax’s approval was supported by data from a randomised Phase III trial (NCT03377491) that evaluated the safety and efficacy of TTFields in combination with gemcitabine and nab-paclitaxel (gem/nab-pac) versus the chemotherapy drugs alone.
The study, called PANOVA-3, followed 571 patients for a minimum 18 months and met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS). Data indicated that 285 patients in the TTFields-gem/nab-pac arm had mOS of 16.2 months, compared to 14.2 months among 286 patients treated with gem/nab-pac alone – reflecting a statistically significant two-month improvement.
In the trial’s modified per protocol (mPP) population, defined as patients who received at least 28 days of Optune Pax therapy with gem/nab-pac or at least one complete cycle of gem/nab-pac, 198 patients treated with Optune Pax concomitantly with gem/nab-pac had a mOS of 18.3 months compared to 15.1 months in 207 patients treated with gem/nab-pac alone. Improvements extended to one-year survival rate – the trial’s secondary endpoint.
Optune Pax was well-tolerated and did not exacerbate gem/nab-pac-related systemic toxicity. No new safety signals were observed, and serious adverse events (SAEs) were comparable between study arms, with the most common being sepsis and cholangitis.
Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH) commented: “Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options.
“This approval provides a novel, non-invasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings.”
Novocure also has a TTFields device known as Optune Lua that gained approval from the FDA in October 2024 for use alongside PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel in adult patients with metastatic non-small cell lung cancer (mNSCLC).
