FDA

Tumor field treatment approved for metastatic NSCLC

October 23, 2024

Novocure GmbH’s Optune Lua is a portable, battery-powered device that generates tumor treating fields (TTFields) through non-invasive, wearable arrays to treat metastatic non-small cell lung cancer (NSCLC) in adults who have progressed on or after platinum-based chemotherapy.

Approval was based on the phase 3 LUNAR trial, a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel to PD-1/PD-L1 inhibitors or docetaxel alone for patients with metastatic NSCLC. According to the manufacturer's press release, results showed a significant 3.3-month extension in median overall survival for patients using Optune Lua with PD-1/PD-L1 inhibitors or docetaxel (13.2 months vs. 9.9 months, P = 0.04).

Novocure’s TTFields technology was previously approved for glioblastoma in 2015 and malignant pleural mesothelioma in 2019.

Sources:

FDA. (2024, October 18). FDA Roundup: October 18, 2024. [Press release]. https://www.fda.gov/news-events/press-announcements/fda-roundup-october-18-2024

Novocure. (2024, October 15). FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer. [Press release]. https://www.novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer/