Novocure Submits PMA Application to FDA for Tumor Treating Fields Therapy in Pancreatic Cancer

Novocure has submitted a premarket approval application to the FDA for its Tumor Treating Fields (TTFields) therapy in locally advanced pancreatic cancer. The application is backed by the PANOVA-3 trial, which showed a significant improvement in median overall survival with TTFields and chemotherapy. An FDA decision on the approval is anticipated in the second half of 2026.

July 2, 2025 - Novocure has submitted a premarket approval application to the U.S. Food and Drug Administration (FDA) for its Tumor Treating Fields (TTFields) therapy to treat locally advanced pancreatic cancer. The application is supported by the phase 3 PANOVA-3 trial, which demonstrated a significant improvement in median overall survival (OS) when TTFields was combined with chemotherapy compared to chemotherapy alone.

The PANOVA-3 trial enrolled 571 patients who were randomly assigned to receive TTFields plus gemcitabine and nab-paclitaxel (Abraxane) or gemcitabine and nab-paclitaxel alone. The addition of TTFields to chemotherapy resulted in a statistically significant and clinically meaningful improvement in median OS, with a median OS of 16.2 months for the TTFields group compared to 14.2 months for the chemotherapy alone group [1].

Novocure expects an FDA decision on the approval in the second half of 2026. The submission of the application is a significant milestone in the company's efforts to expand the use of TTFields therapy, which has previously been approved for the treatment of glioblastoma and non-small cell lung cancer.

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