Novocure receives Japanese approval for Optune Pax pancreatic cancer device

Japan has approved a wearable cancer treatment for adults with unresectable locally advanced pancreatic cancer. Novocure NASDAQNVCR, a Swiss developer of tumour-treating field devices, said on Oct. 1 its Optune Pax can be used alongside gemcitabine and nab-paclitaxel.

Shares traded at US$16.10 on Nasdaq at 9:55 a.m. EDT on Oct. 1, according to NASDAQNVCR. They were up 0.94 per cent at 9:55 a.m. EDT on Oct. 1, according to the same NASDAQNVCR quote. Novocure reported July 23 that Japan produced US$11.8 million in revenue in the quarter ended June 30 from its existing product portfolio.

Japan's Ministry of Health, Labour and Welfare approved Optune Pax for use with the two chemotherapy drugs. The Oct. 1 announcement gave no date for Japanese shipments, a national insurance coverage decision or a forecast of Japanese Optune Pax revenue.

The published PANOVA-3 study randomized 571 newly diagnosed patients to chemotherapy with or without tumour-treating fields. Its open-label trial ran at 196 sites in 20 countries. The paper's abstract reports median overall survival of 16.2 months with the device and 14.2 months without it, with a P value of .039.

PANOVA-3 Reports Longer Overall Survival

The study found no significant improvement in progression-free survival, local progression-free survival or overall response rate. Its published abstract reports median pain-free survival of 15.2 months with the device, compared with 9.1 months without it. The global trial's results underpinned Japan's decision, Novocure said in its Oct. 1 release.

"In the Phase 3 PANOVA-3 trial for Optune Pax, there was a statistically significant improvement in overall survival and pain progression was delayed, helping to preserve overall quality of life for people with this disease," Makoto Ueno, MD, PhD, director of gastroenterology at the Kanagawa Cancer Center in Yokohama, said in Novocure's Oct. 1 release.

Skin tolerance is one practical test for a device worn during treatment. The PANOVA-3 paper reported device-related skin events in 76.3 per cent of device users. In its Oct. 1 release, Novocure said 7.7 per cent had events of grade 3 or worse. The company said serious adverse events were comparable between the treatment arms.

In an accompanying Journal of Clinical Oncology editorial, Johns Hopkins oncologist Michael J. Pishvaian, MD, PhD, cited early dropout of nearly 30 per cent and median daily device use of 62 per cent, short of the recommended 75 per cent. He also flagged the lack of central imaging review to confirm the patients' disease stage.

Japan Approved Optune Lua Reimbursement in March

Novocure's Oct. 1 release noted that the U.S. Food and Drug Administration approved Optune Pax in February 2026 and that the device received a European CE Mark in June. Its July 23 results named Germany as the first European launch market. Neither development sets a Japanese shipment date.

Novocure's April 30 results said Japan's Ministry of Health, Labour and Welfare approved national insurance reimbursement for Optune Lua in March 2026. The report described Lua's Japanese approval for certain patients with non-small cell lung cancer, a different indication from Pax. By June 30, Novocure counted 64 Japanese patients active on Lua and US$1.8 million in quarterly Japanese Lua revenue.

The U.S. rollout of Pax supplies another dated comparison. Following the February 2026 FDA decision, Novocure counted 83 active U.S. Optune Pax patients on March 31 in its April report. Its July 23 results counted 285 active U.S. patients on June 30 and US$1.6 million in total Optune Pax revenue for the second quarter.

Novocure held US$440.6 million in cash, equivalents and short-term investments at June 30. Its July 23 results put second-quarter sales and marketing expense at US$61.7 million, up 8 per cent from a year earlier, primarily because of U.S. Pax and Japanese Lua launch costs. That report did not break out a Japanese Pax launch budget.

The July 23 guidance projected US$20 million to US$30 million in combined 2026 net revenue from Optune Lua and Optune Pax across markets. It did not allocate any amount to Japanese Optune Pax sales, while the Oct. 1 approval release gave no Japanese price or reimbursement timetable.

The Approval Release Gives No Japan Launch Date

A Sept. 29 Mugglehead report on medical software clearance recorded another regulatory milestone without a rollout date. Tempus AI, Inc. NASDAQTEM, a Chicago medical software developer, said Sept. 28 its ECG-MR tool received FDA clearance but did not say when clinics could use it. That U.S. clearance concerns screening software, while Novocure's Japanese approval covers a cancer treatment device.

Read more: Tempus AI wins FDA clearance for fourth ECG tool targeting mitral regurgitation

Novocure announced Japanese approval on Oct. 1, the first day of the quarter ending Dec. 31, 2026. Its release gives no date for the first Japanese Optune Pax shipments, reimbursement decision or revenue.