At a Glance
- FDA approved Optune Pax for adults with locally advanced pancreatic cancer
- Approval supported by Phase 3 PANOVA-3 trial results
- Study showed improvement in median overall survival
- Device-based TTFields therapy used with standard chemotherapy
Written By: Pharmacally Medical News Desk
Novocure reported that the U.S. Food and Drug Administration approved Optune Pax® for use in adults with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel (Novocure pancreatic cancer therapy). The decision introduces a device-based therapy into a setting where treatment options have remained largely unchanged for years, marking the first new standard in years.
Optune Pax delivers Tumor Treating Fields (TTFields), a biophysical therapy that uses alternating electric fields to disrupt cancer cell division through multiple mechanisms (TTFields PANOVA-3 trial results).
The portable system applies the fields non-invasively through wearable arrays, selectively targeting tumor cells while largely sparing healthy tissue due to differences in cellular properties.
Due to its multi-mechanistic action, TTFields therapy can be combined with established treatments, including chemotherapy, radiotherapy, and targeted therapies, where studies have demonstrated enhanced anti-tumor effects across solid tumor models.
The approval is supported by findings from the Phase 3 PANOVA-3 trial, an international, randomized, open-label study that enrolled 571 patients with locally advanced pancreatic cancer (NCT03377491). Participants received either Optune Pax plus gemcitabine/nab-paclitaxel or chemotherapy alone.
In the intent-to-treat population, median overall survival reached 16.2 months in the Optune Pax arm compared with 14.2 months for chemotherapy alone. The study reported a hazard ratio of 0.82 (95% CI: 0.68–0.99; p=0.039), reflecting a statistically significant survival improvement.
Among patients meeting modified per-protocol criteria (defined as those receiving at least 28 days of Optune Pax therapy concomitant with chemotherapy), median overall survival extended to 18.3 months with Optune Pax versus 15.1 months in the control group (HR 0.77; 95% CI: 0.62–0.97; p=0.023).
Secondary analyses showed higher one-year survival rates. In the intent-to-treat population, survival at one year reached 68.1% with Optune Pax compared with 60.2% for chemotherapy alone. The modified per-protocol population demonstrated a similar trend.
The study also evaluated symptom-related outcomes. Median time to pain progression measured 15.2 months in the Optune Pax group compared with 9.1 months in the chemotherapy-only arm, representing a 6.1-month difference. Quality-of-life assessments indicated delayed deterioration across several domains, including global health status and pain measures.
Investigators did not observe statistically significant differences in progression-free survival, objective response rate, or tumor resectability between study arms. Safety findings aligned with expectations for TTFields therapy.
Most patients receiving Optune Pax experienced device-related skin reactions beneath the arrays. The majority of these events were mild to moderate. Serious adverse events and systemic toxicities were comparable between treatment groups, and no new safety signals were identified.
The PANOVA-3 results were published in the Journal of Clinical Oncology.
Pancreatic cancer remains one of the most lethal malignancies with a 5-year survival rate of just 13% across stages and even lower for locally advanced disease. with rising incidence and limited survival gains over recent decades. Patients with locally advanced disease often face restricted therapeutic options, particularly when tumors are not surgically resectable. The FDA approval positions TTFields therapy as an additional treatment approach in a disease setting marked by persistent unmet need, via Pharmacally.com.
Reference
U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer, 11 February 2026, https://www.novocure.com/us-fda-approves-novocures-optune-paxr-treatment-locally-advanced-pancreatic-cancer
Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant with Gemcitabine and Nab-paclitaxel (PANOVA-3), ClinicalTrials.gov ID NCT03377491, https://clinicaltrials.gov/study/NCT03377491
Babiker HM et al, Tumor Treating Fields with Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study. J Clin Oncol. 2025 Jul 20;43(21):2350-2360. Epub 2025 May 31. PMID: 40448572, https://doi.org/10.1200/jco-25-00746