Novocure (NSDQ:NVCR) announced today that the FDA granted breakthrough designation for its NovoTTF-200T liver cancer treatment system.
St. Helier, Jersey-based Novocure designed its NovoTTF-200T system, a tumor treating fields (TTFields) delivery system for use in tandem with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.
According to a news release, the FDA granted breakthrough device designation based on clinical data from Novocure’s Phase 2 pilot Hepanova trial evaluating the safety and efficacy of TTFields together with sorafenib for treating advanced liver cancer.
TTFields, electric fields designed to disrupt cancer cell division, are intended principally for use with other standard-of-care cancer treatments, as Novocure touts a body of evidence supporting its broad applicability with other cancer therapies, including radiation along with certain chemotherapies and immunotherapies.
Clinical research and commercial experience to date demonstrates that TTFields exhibit no systemic toxicity, with mild to moderate skin irritation constituting the most common side effect. Use of TTFields for treating liver cancer is investigational only.
“We are very pleased that the FDA has granted breakthrough designation for Tumor Treating Fields together with atezolizumab and bevacizumab to treat advanced liver cancer,” Novocure CEO Asaf Danziger said in the release. “Our data suggest that TTFields have the potential to extend survival in this particularly aggressive disease. We are working closely with trial investigators and intend to initiate a randomized controlled trial studying TTFields in combination with atezolizumab and bevacizumab as soon as possible.”