FDA Designates NovoTTF-200T System for Liver Cancer Breakthrough Device

The FDA has granted breakthrough device designation to Novocure’s NovoTTF-200T system, which is designed to disrupt cancer cell division by delivering electric “fields.”

The device is intended for use with Genentech’s Tecentriq (atezolizumab) and Avastin (bevacizumab) for the first-line treatment of patients with unresectable or metastatic liver cancer.

The FDA granted the breakthrough device designation in part based on positive results from a phase 2 trial, which tested the investigational technology with Bayer’s Nexavar (sorafenib) for the treatment of advanced liver cancer.