Three approved TTFields devices, $710M+ revenue guidance, but GBM expansion just failed — Optune Lua's brain-mets PMA is now the growth thesis

NovoCure is a commercial-stage medical-device company with three approved Tumor Treating Fields devices treating cancer, whose growth now depends on FDA approval of an unapproved device for brain metastases after a failed expansion trial in a different brain-cancer indication.

NovoCure has built a three-indication commercial franchise on Tumor Treating Fields, a physical oncology modality, with Optune Pax's February 2026 approval marking the first new locally advanced pancreatic cancer treatment in roughly 30 years. The TRIDENT Phase 3 miss in newly diagnosed glioblastoma removes the largest potential revenue expansion, shifting the entire growth case onto Optune Lua's FDA decision on brain metastases from NSCLC. The brain-mets PMA rests on Phase 3 METIS data, and the key risk is whether FDA accepts that dataset under a PMA pathway for a population with active intracranial disease.