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Pancreatic cancer treatment enters new era

Pancreatic cancer treatment enters new era

New Capabilities
By Newzino Staff | |

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—and for decades, patients diagnosed with locally advanced disease had essentially one option: chemotherapy that extended life by months, not years. On February 11, 2026, that changed. The Food and Drug Administration approved Optune Pax, a portable device that delivers alternating electrical fields to the abdomen, marking the first new FDA-approved treatment for locally advanced pancreatic cancer in nearly three decades.

The approval rests on the Phase 3 PANOVA-3 trial, which showed patients receiving the device alongside standard chemotherapy lived a median of 16.2 months—roughly two months longer than chemotherapy alone. Perhaps more significant: 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. The technology represents a fourth modality of cancer treatment—joining surgery, radiation, and chemotherapy—using electric fields to disrupt cancer cell division while leaving healthy tissue largely intact.

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
Novocure Founder and Chief Technology Officer (Active; recipient of 2022 Israel Prize for entrepreneurship)
Ashley Cordova
Ashley Cordova
Chief Executive Officer, Novocure (Former CEO (succeeded, based on recent statement from Frank Leonard))
Vincent Picozzi
Vincent Picozzi
Medical Oncologist and PANOVA-3 Trial Investigator (Active)
Anna Berkenblit
Anna Berkenblit
Chief Scientific and Medical Officer, Pancreatic Cancer Action Network (PanCAN) (Active)
Frank Leonard
Frank Leonard
Chief Executive Officer, Novocure (Active (noted in recent statement))

Organizations Involved

Novocure
Novocure
Biotechnology Company
Status: 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 Regulatory Agency
Status: 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

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

    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.

Scenarios

1

TTFields Becomes Standard of Care for Locally Advanced Pancreatic Cancer

Discussed by: Oncology publications including OncLive and Targeted Oncology; Pancreatic Cancer Action Network

With FDA approval secured and Phase 3 data showing survival and quality-of-life benefits, Optune Pax could be incorporated into treatment guidelines from organizations like the National Comprehensive Cancer Network. Adoption would depend on insurance coverage, patient tolerance of wearing the device, and oncologist familiarity with the technology. Novocure's experience expanding glioblastoma treatment provides a template for commercialization.

2

Expansion to Metastatic Pancreatic Cancer

Discussed by: Financial analysts covering Novocure; biotech industry publications

Novocure could pursue trials in metastatic pancreatic cancer, where survival is even shorter (median 3-11 months depending on treatment). Success would dramatically expand the addressable patient population. However, the challenge of treating widely distributed tumors with localized electric fields may limit efficacy compared to locally advanced disease.

3

Combination Therapies Amplify Benefit

Discussed by: MD Anderson Cancer Center researchers; clinical oncology journals

Researchers are exploring whether TTFields can enhance the effectiveness of emerging therapies such as KRAS inhibitors or immunotherapy. Early evidence suggests electric fields may increase drug penetration and tumor immunogenicity. If combination approaches succeed, the two-month survival benefit could expand significantly.

4

Adoption Limited by Cost and Compliance

Discussed by: Healthcare economics analysts; patient advocacy organizations

The Optune system requires patients to wear electrode arrays on their abdomen for at least 18 hours daily. Compliance challenges and potential insurance coverage limitations could restrict real-world adoption. In glioblastoma, patients who used the device more than 90% of the time showed the best outcomes—suggesting that less-compliant patients may see diminished benefit.

Historical Context

Gemcitabine Approval Changes Pancreatic Cancer Standard of Care (1996)

May 1996

What Happened

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.

Outcome

Short Term

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

Long Term

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 It's Relevant Today

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.

Optune Approved for Glioblastoma (2011)

April 2011

What Happened

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.

Outcome

Short Term

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

Long Term

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 It's Relevant Today

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.

FOLFIRINOX Trial Extends Pancreatic Cancer Survival (2011)

May 2011

What Happened

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.

Outcome

Short Term

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

Long Term

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 It's Relevant Today

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.

11 Sources:
+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