Optune Pax (Tumor Treating Fields) was approved by the FDA for adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel; the approval was announced on February 11, 2026.
The FDA approved Optune Pax, Novocure's Tumor Treating Fields device for locally advanced pancreatic cancer, on February 11, 2026 (premarket approval P250034). Novocure announced the approval the same day.
This is a device premarket approval (CDRH), not a drug application. The FDA's PMA database records P250034 with decision date February 11, 2026 for adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel (FDA PMA record). Novocure's release of February 11, 2026 is filed as an exhibit to its 8-K (8-K exhibit). Correction, October 14, 2026: an earlier page on this site dated this decision February 12, 2026; the FDA's decision and Novocure's announcement were both February 11.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Novocure 8-K exhibit, February 11, 2026; FDA PMA P250034 decision February 11, 2026
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Yes. The approval of the application for Optune Pax (Tumor Treating Fields) was announced on February 11, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Optune Pax (Tumor Treating Fields) is a Novocure (NVCR) program. The company announced the FDA decision on February 11, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), NVCR moved -11.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.