Second generation Optune system filed with FDA for Brain cancer-Novocure

Novocure has filed a premarket approval (PMA) supplement application for its new, second generation Optune system with the FDA on Dec. 22, 2015. FDA approval of the PMA supplement is required before Novocure can make the improved Optune system available to glioblastoma patients in the U.S. The new model features a TTFields generator that is half the size and half the weight of the current system. The second generation Optune system, including its battery, weighs 2.7 pounds (1.3 kilograms) compared to the current version that weighs 6 pounds (3 kilograms).

The improvements of the second generation Optune system were achieved using novel digital signal generation technology. Novocure started offering the second generation Optune device to patients in Germany in October 2015 and has since made it available to all new patients throughout Europe. Novocure is in the process of upgrading European patients who previously started TTFields therapy on the first generation Optune.