On September 9, 2021 Novocure (NASDAQ: NVCR) reported the United States Food and Drug Administration (FDA) has granted breakthrough designation to the NovoTTF-200T System, a Tumor Treating Fields (TTFields) delivery system intended for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer (Press release, NovoCure, SEP 9, 2021, View Source [SID1234587552]). The designation offers Novocure an opportunity to interact with FDA experts through several different program options to address regulatory topics efficiently as they arise during the premarket review phase and allows for prioritized review of regulatory submissions.

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The FDA granted breakthrough device designation in part based on clinical data from Novocure’s phase 2 pilot HEPANOVA trial testing the safety and efficacy of TTFields together with sorafenib for the treatment of advanced liver cancer. In granting the designation, the FDA determined that the TTFields delivery system for advanced liver cancer is a breakthrough technology that has the potential to be a more effective treatment for this life-threatening condition, and therefore meets the FDA’s stringent requirements for breakthrough device designation.

"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," said Asaf Danziger, Novocure’s CEO. "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."

TTFields are electric fields that disrupt cancer cell division. TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields have exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

Use of Tumor Treating Fields for the treatment of liver cancer is investigational only.

About Liver Cancer

Liver cancer is a leading cause of cancer deaths worldwide and is the sixth leading cause of cancer deaths annually in the U.S. The incidence of liver cancer is approximately 42,000 new cases annually in the U.S. The five-year survival rate with existing standards of care is less than 20%.

Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver. Advanced liver cancer has spread either to the lymph nodes or to other organs and because these cancers are widespread, they cannot be treated with surgery. The current common standard treatment for patients with advanced disease and those who progressed on loco-regional therapy is systemic therapy with sorafenib, lenvatinib, or atezolizumab plus bevacizumab.