FDA Approves Novocure's Optune Pax for Locally Advanced Pancreatic Cancer

Optune Pax concomitant with gemcitabine and nab-paclitaxel is the first treatment approved in nearly 30 years for this disease

Published on Feb. 11, 2026

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The U.S. Food and Drug Administration (FDA) has approved Novocure's Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer, to be used concomitantly with gemcitabine and nab-paclitaxel chemotherapy. The Phase 3 PANOVA-3 trial showed Optune Pax resulted in a statistically significant improvement in median overall survival compared to chemotherapy alone, without adding to systemic side effects.

Why it matters

Pancreatic cancer is one of the most lethal forms of cancer, with a 5-year survival rate of just 13%. Treatment options have remained limited, underscoring the importance of new approaches like Optune Pax that utilize a biophysical mechanism to target cancer cells. This approval represents meaningful progress for patients with locally advanced pancreatic cancer who urgently need more effective treatment options.

The details

Optune Pax is a portable therapeutic device that delivers Tumor Treating Fields (TTFields), alternating electric fields that disrupt cancer cell division and survival. In the PANOVA-3 trial, patients treated with Optune Pax plus chemotherapy had a median overall survival of 16.2 months, compared to 14.2 months for chemotherapy alone - a statistically significant 2-month improvement. Optune Pax also significantly extended time to pain progression, helping preserve quality of life.

  • The FDA approved Optune Pax on February 11, 2026.

The players

Novocure

An American oncology company that developed Optune Pax and is commercializing the therapy.

Vincent Picozzi, M.D., MMM

A medical oncologist and investigator in the PANOVA-3 clinical trial of Optune Pax.

Frank Leonard

The CEO of Novocure.

Anna Berkenblit, MD, MMSc

The Chief Scientific and Medical Officer of the Pancreatic Cancer Action Network (PanCAN).

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What they’re saying

“In the Phase 3 PANOVA-3 trial, treatment with Optune Pax resulted in a statistically significant improvement in overall survival without adding to the systemic side effects commonly associated with existing therapies. It also significantly extended time to pain progression, helping to preserve overall quality of life, which is a priority when I am treating patients living with pancreatic cancer.”

— Vincent Picozzi, M.D., MMM, Medical oncologist and investigator in the PANOVA-3 trial

“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 tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells.”

— Frank Leonard, CEO, Novocure

“The approval of Optune Pax is an important milestone for the pancreatic cancer community. Survival rates for pancreatic cancer have seen only modest improvements over time and treatment advances have remained limited, underscoring how challenging this disease is to treat. This approval for locally advanced disease highlights the importance of continued innovation and investment in new approaches for difficult-to-treat cancers and represents meaningful progress for patients who urgently need more options.”

— Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer, Pancreatic Cancer Action Network

What’s next

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The takeaway

This approval of Optune Pax represents an important advancement in the treatment of locally advanced pancreatic cancer, a devastating disease with limited treatment options. By utilizing a novel biophysical approach, Optune Pax has the potential to meaningfully improve outcomes for patients without adding to the significant side effects of existing therapies.