FDA grants IDE to NovoCure for phase II Optune trial

NovoCure (NSDQ:NVCR) said today that Radiation Therapy Oncology Group Foundation won FDA investigational device exemption to conduct a Phase II pilot test of NovoCure’s Optune in conjunction with bevacizumab to treat bevacizumab-refractory recurrent glioblastoma. The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit cancer cell replication and cause cancer cell death. “This is the 1st consortium study of TTFields, representing a growing interest in TTFields therapy from the scientific community. We are excited that the RTOG is researching the potential benefit of TTFields therapy together with bevacizumab in this difficult-to-treat population of patients. A post hoc analysis of the EF-14 phase 3 trial in newly diagnosed glioblastoma patients suggested that adding TTFields to chemotherapy or bevacizumab after disease progression may extend overall survival. The RTOG trial will test this finding prospectively in a subgroup of recurrent GBM patients who have a very poor prognosis,” NovoCure chief science officer Dr. Eilon Kirson said in a press release. The newly cleared study is slated to enroll 85 patients with a recurrence or progression of glioblastoma or other grade IV glioma after treatment with bevacizumab. The trial aims to explore the efficacy of TTFields therapy together with bevacizumab, measured by overall survival at 6 months,...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Oncology NovoCure Source Type: news