Novocure (Nasdaq:NVCR) announced today that it submitted an FDA premarket approval (PMA) application for its tumor-treating fields therapy.
The company submitted its Optune Lua wearable device that delivers TTFields therapy for the treatment of locally advanced pancreatic cancer. Optune Lua already has FDA approval for treating non-small cell lung cancer (NSCLC), which it picked up in October 2024. It earned CE mark approval for NSCLC about six months later.
Using arrays adhered to the skin, Optune Lua delivers the electrical TTFields continuously and directly to the tumor site. Through non-invasive, wearable arrays, it exerts physical forces on the electrically charged components of the dividing cancer cells.
Small and lightweight at just 2.7 pounds (with a battery), it offers a wearable, portable option for continuing normal daily activities. The company designed it for enhanced carrying comfort and usability.
Data from the PANOVA-3 trial evaluating TTFields therapy used concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone, supported the submission. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median overall survival.
Novocure submitted the device for a PMA supplement, which it expects to convert to a separate, original PMA for pancreatic cancer. It anticipates an approval decision in the second half of 2026.
“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,” said Ashley Cordova, CEO, Novocure. “This milestone, achieved nine months after the positive topline 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.”
