Novocure Submits Tumor Treating Fields Therapy for Pancreatic Cancer to FDA

Novocure has submitted a premarket approval application to the FDA for its Tumor Treating Fields therapy to treat locally advanced pancreatic cancer. The company expects a decision in the second half of 2026.

Novocure Limited, a company specializing in tumor treating fields (TTFields) therapy, has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the use of TTFields therapy in the treatment of locally advanced pancreatic cancer. The company expects a decision on the application in the second half of 2026.

The submission is based on the findings of the phase 3 PANOVA-3 trial, which evaluated the use of TTFields therapy in conjunction with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma. The trial demonstrated a statistically significant and clinically meaningful improvement in median overall survival for patients treated with TTFields and GnP compared to GnP alone. The primary endpoint of the study was overall survival, and it met this endpoint successfully.

The PANOVA-3 trial enrolled 571 patients who were randomly assigned to either TTFields plus gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. The median overall survival was 16.2 months for the TTFields plus chemotherapy group compared to 14.2 months for the chemotherapy alone group. The trial also showed improvements in pain-free survival and distant progression-free survival with the addition of TTFields.

The Optune Lua device, which delivers TTFields therapy, was used in the trial. This device is already approved by the FDA for the treatment of non-small cell lung cancer (NSCLC) and is designed to be worn continuously, allowing patients to maintain a normal daily routine. The device is small and lightweight, weighing just 2.7 pounds, and is designed for comfort and usability.

Novocure anticipates that the PMA for pancreatic cancer will be converted to a separate, original PMA, and the company's CEO, Ashley Cordova, emphasized the significance of this milestone in advancing TTFields therapy as a treatment option for people living with pancreatic cancer.

This submission marks a significant step in Novocure's efforts to bring innovative cancer treatment options to patients. The company's focus on improving patient outcomes through clinical trials and regulatory approvals underscores its commitment to advancing the field of oncology.

References:
[1] https://www.marketscreener.com/news/novocure-limited-submits-premarket-approval-application-to-fda-for-tumor-treating-fields-therapy-in-ce7c51d2dc88f223
[2] https://www.onclive.com/view/novocure-files-premarket-approval-application-to-fda-for-tumor-treating-fields-in-locally-advanced-pancreatic-cancer
[3] https://www.massdevice.com/novocure-submits-ttfields-device-fda-pma/