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Pancreatic cancer treatment enters new era

Pancreatic cancer treatment enters new era

New Capabilities

FDA Approves First New Treatment for Locally Advanced Disease in Nearly 30 Years

February 13th, 2026: Novocure Releases Detailed PANOVA-3 Data and Physician Statements

Overview

Pancreatic cancer has been oncology's grimmest frontier. The five-year survival rate sits at 13 percent.

For decades, patients with locally advanced disease had one option: chemotherapy that extended life by months, not years. On February 11, 2026, the FDA approved Optune Pax, the first new treatment for locally advanced pancreatic cancer in nearly three decades. It delivers alternating electrical fields to the abdomen — a fourth modality of cancer treatment, joining surgery, radiation, and chemotherapy, using the fields to disrupt cancer cell division while leaving healthy tissue largely intact.

The approval rests on the Phase 3 PANOVA-3 trial. Patients receiving the device alongside standard chemotherapy lived a median of 16.2 months — roughly two months longer than chemotherapy alone. Pain-free survival extended from 9.1 to 15.2 months, a six-month improvement for patients facing one of cancer's most painful diseases.

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Key Indicators

16.2
Median survival (months)
Patients receiving Optune Pax plus chemotherapy versus 14.2 months with chemotherapy alone
15.2
Pain-free survival (months)
Extended from 9.1 months in chemotherapy-only group—a 6.1-month improvement
13%
Five-year survival rate
Pancreatic cancer remains among the deadliest cancers, though survival has improved from 7% a decade ago
67,440
New U.S. cases annually
Estimated diagnoses in 2025; approximately 52,000 Americans die from the disease each year

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People Involved

Yoram Palti
Yoram Palti
Active; recipient of 2022 Israel Prize for entrepreneurship
 Ashley Cordova
Ashley Cordova
Former CEO (succeeded, based on recent statement from Frank Leonard)
 Vincent Picozzi
Vincent Picozzi
Active
 Anna Berkenblit
Anna Berkenblit
Active
 Frank Leonard
Frank Leonard
Active (noted in recent statement)

Organizations Involved

Novocure
Novocure
Biotechnology Company
Publicly traded; expanding beyond glioblastoma into multiple solid tumors

Developer of tumor treating fields technology, a fourth modality of cancer treatment using alternating electric fields to disrupt cancer cell division.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Granted approval; previously designated Optune Pax as Breakthrough Device in December 2024

Federal agency responsible for approving medical devices and drugs for use in the United States.

Timeline

May 1996 February 2026

10 events Latest: February 13th, 2026 · 3 months ago
Tap a bar to jump to that date

  1. Novocure Releases Detailed PANOVA-3 Data and Physician Statements

    Latest Corporate

    Novocure published detailed Phase 3 PANOVA-3 results showing one-year survival rate of 68.1% with Optune Pax plus chemotherapy vs. 60.2% with chemotherapy alone; included endorsements from trial investigator Vincent Picozzi, M.D., and PanCAN's Anna Berkenblit, M.D.

  2. FDA Approves Optune Pax for Pancreatic Cancer

    Regulatory

    The FDA approved Optune Pax, the first new treatment for locally advanced pancreatic cancer in nearly 30 years. The device delivers tumor treating fields to the abdomen alongside chemotherapy.

  3. PANOVA-3 Results Presented at ASCO

    Research

    Novocure presented final PANOVA-3 trial results at the American Society of Clinical Oncology annual meeting, showing statistically significant overall survival improvement.

  4. Breakthrough Device Designation Granted

    Regulatory

    The FDA granted Breakthrough Device designation to Optune Pax for locally advanced pancreatic cancer, accelerating the review process.

  5. NALIRIFOX Approved for Metastatic Disease

    Regulatory

    The FDA approved irinotecan liposome (Onivyde) with oxaliplatin, fluorouracil, and leucovorin as the NALIRIFOX regimen for first-line treatment of metastatic pancreatic cancer.

  6. Nab-Paclitaxel Combination Approved

    Regulatory

    The FDA approved nab-paclitaxel (Abraxane) for use with gemcitabine in metastatic pancreatic cancer, establishing a new standard combination.

  7. FOLFIRINOX Trial Published

    Research

    The New England Journal of Medicine published results showing the four-drug FOLFIRINOX regimen extended median survival to 11.1 months versus 6.8 months for gemcitabine alone in metastatic pancreatic cancer.

  8. First FDA Approval for Tumor Treating Fields

    Regulatory

    The FDA approved Novocure's Optune device for recurrent glioblastoma, validating the TTFields approach for the first time.

  9. Novocure Founded

    Corporate

    Yoram Palti founded Novocure based on his discovery that alternating electric fields could disrupt cancer cell division.

  10. Gemcitabine Approved for Pancreatic Cancer

    Regulatory

    The FDA approved gemcitabine (Gemzar), establishing the first standard-of-care chemotherapy for advanced pancreatic cancer. It remained the backbone of treatment for decades.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

May 1996

Gemcitabine Approval Changes Pancreatic Cancer Standard of Care (1996)

The FDA approved gemcitabine (Gemzar) for advanced pancreatic cancer based on trials showing improved clinical benefit response over fluorouracil. Approximately one-quarter of patients achieved marked symptom relief. The drug became the backbone of pancreatic cancer treatment.

Then

Gemcitabine established the first evidence-based standard of care for advanced pancreatic cancer, replacing fluorouracil as first-line treatment.

Now

For nearly three decades, gemcitabine remained central to pancreatic cancer treatment. New regimens like FOLFIRINOX and gemcitabine-nab-paclitaxel built upon rather than replaced it. The Optune Pax approval marks the first entirely new modality added since.

Why this matters now

The Optune Pax approval is significant precisely because the treatment landscape has been so static. Adding two months of survival to a gemcitabine-based backbone represents the first non-chemotherapy option for locally advanced patients in 30 years.

April 2011

Optune Approved for Glioblastoma (2011)

The FDA approved Novocure's Optune device for recurrent glioblastoma, making it the first tumor treating fields device to reach market. The approval came after years of medical community skepticism about bioelectronic medicine. Initial adoption was slow.

Then

Oncologists gradually incorporated TTFields into glioblastoma treatment as clinical experience accumulated. Insurance coverage expanded over several years.

Now

The EF-14 trial showed patients using Optune with temozolomide had median survival of 20.8 months versus 16 months for chemotherapy alone—and a 13% five-year survival rate, remarkable for glioblastoma. The success validated TTFields and paved the way for expansion to other cancers.

Why this matters now

The glioblastoma approval demonstrated that TTFields could improve survival in a notoriously difficult cancer. Novocure's subsequent approvals in mesothelioma, non-small cell lung cancer, and now pancreatic cancer follow the same playbook: prove efficacy in Phase 3 trials for cancers with few options.

May 2011

FOLFIRINOX Trial Extends Pancreatic Cancer Survival (2011)

French researchers published results showing the four-drug FOLFIRINOX regimen extended median survival to 11.1 months versus 6.8 months for gemcitabine alone in metastatic pancreatic cancer—a 4.3-month improvement, the largest ever seen in a Phase 3 pancreatic cancer trial at the time.

Then

FOLFIRINOX became the preferred regimen for fit patients with metastatic disease, despite more severe side effects than gemcitabine.

Now

The trial demonstrated that meaningful survival gains were possible in pancreatic cancer and reinvigorated research interest. However, the regimen's toxicity limited its use to patients with good performance status.

Why this matters now

The FOLFIRINOX breakthrough showed that survival improvements of 4+ months were achievable in pancreatic cancer. Optune Pax's 2-month improvement is more modest but represents an entirely different approach—and one that may combine with existing chemotherapy rather than compete with it.

Sources

(11)
+5
U.S. Food and Drug Administration GlobeNewswire CURE Journal of Clinical Oncology Novocure Pancreatic Cancer Action Network National Cancer Institute SEER Program New England Journal of Medicine American Cancer Society OncLive Novocure