Novocure files for FDA approval of TTFields for pancreatic cancer
Decision expected in second half of 2026, should application be accepted
Novocure has filed an application asking the U.S. Food and Drug Administration to approve its Tumor Treating Fields (TTFields) therapy for treating locally advanced pancreatic cancer.
The premarket approval application was filed a few months after a large Phase 3 clinical trial called PANOVA-3 (NCT03377491) showed that patients treated with TTFields plus chemotherapy lived longer with fewer symptoms and manageable side effects compared with chemotherapy alone.
“The submission of our application is a key step in our efforts to advance Tumor Treating Fields therapy as a treatment option for people living with pancreatic cancer,” Ashley Cordova, CEO of Novocure, said in a company press release.
The therapy is already approved in the U.S. under the brand name Optune Lua to treat a type of lung cancer. With the new application, the company hopes to expand its use to unresectable, locally advanced pancreatic cancer, which is inoperable.
“This milestone, achieved nine months after the positive [top-line] readout of the PANOVA-3 trial, reflects the focus, drive, and commitment of our team to bring this innovative treatment to patients as quickly as possible,” Cordova said.
Novocure is expecting a decision in the second half of 2026, should the application be accepted for review.
Regulatory approval of TTFields to be sought in China
In China, where Zai Lab is collaborating with Novocure to develop and market TTFields, the therapy has received Innovative Medical Device Designation. With this designation, Chinese regulators may focus more resources on reviewing the therapy quickly, speeding up the approval process.
“This designation also allows us to submit the application in China before approval in the country of origin,” Rafael Amado, MD, president and head of global research and development at Zai Lab, said in another press release. “We are on track to submit for regulatory approval in China in the second half of 2025.”
TTFields uses low-intensity electric fields — delivered through a portable device worn on the body — to interfere with the way cancer cells grow and divide. Because cancer cells divide much faster than normal cells, they are more susceptible to this type of therapy, while healthy cells are left unharmed.
In the PANOVA-3 trial, 571 patients with pancreatic cancer that could not be operated on were randomly assigned to receive first-line treatment with TTFields alongside standard chemotherapy (gemcitabine and nab-paclitaxel), or chemotherapy alone.
The main goal of the trial was to assess overall survival, meaning how long patients lived after treatment.
We are on track to submit for regulatory approval in China in the second half of 2025..
Results showed that patients who received TTFields in combination with chemotherapy lived a median of 16.2 months, while those who were treated with chemotherapy alone lived 14.2 months.
Researchers also examined other outcomes, including how long patients lived without pain, the number of patients who were alive after one year, and overall quality of life. The TTFields group showed improvements in these areas, with more patients living pain-free for longer and experiencing better one-year survival. Quality of life related to pain and digestive health was also maintained.
In terms of safety, the most common side effects from TTFields were skin reactions, such as mild to moderate irritation where the device was applied. These were generally manageable, and no unexpected safety concerns were reported.
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