Novocure announced that the U.S. Food and Drug Administration (FDA) approved Optune Pax®? for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel. In the Phase 3 PANOVA-3 trial, treatment with Optune Pax resulted in a statistically significant improvement in overall survival without adding to the systemic side effects commonly associated with existing therapies.
It also significantly extended time to pain progression, helping to preserve overall quality of life, which is a priority when I am treating patients living with pancreatic cancer. Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a portable therapeutic device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays.
TTFields are alternating electric fields that target the electrical properties of cancer cells to disrupt processes critical for cancer cell division and survival, resulting in cell death without significantly affecting healthy cells. The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer. Systemic therapy have shown poor bioavailability in cancer tumors, limiting their effectiveness.
Data Supporting the Optune Pax FDA Approval: PANOVA-3 was an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to evaluate the use of Optune Pax concomitantly with gemcitabine and grab-paclitaxel (gem/nab-pac) as a first-line treatment for locally advanced pancreatic cancer compared to gem/nab-pac alone. The trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months. There was one Grade 4 AE suspected to be related to the device by the investigator, which was a non- serious event of neutrophil count decrease.
There were no device-related AE that led to death, and no unanticipated device-related safety issues during the course of the study.
