Novocure has received the US Food and Drug Administration (FDA) breakthrough device designation for its NovoTTF-200T System to treat liver cancer.
NovoTTF-200T is a Tumor Treating Fields (TTFields) delivery system that is designed for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.
Primarily intended for use together with other standard-of-care cancer treatments, TTFields are electric fields that disrupt cancer cell division.
The break through device designation is said to facilitate prioritised review of the device, and provides an opportunity for Novocure to address regulatory topics during the review.
Novocure CEO Asaf Danziger said: “We are very pleased that the FDA has granted breakthrough designation for Tumour Treating Fields together with atezolizumab and bevacizumab to treat advanced liver cancer.
“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 randomised controlled trial studying TTFields in combination with atezolizumab and bevacizumab as soon as possible.”
The US regulatory agency’s breakthrough device designation for NovoTTF-200T is partly based on clinical data from the company’s Phase 2 pilot HEPANOVA trial.
The Phase 2 study evaluated the safety and efficacy of TTFields, in combination with sorafenib for the treatment of advanced liver cancer.
Novocure said that a growing body of evidence suggests that TTFields are widely applicable with certain other cancer therapies, including certain radiation, chemo and immunotherapies.
Also, TTFields have demonstrated no systemic toxicity in clinical research and commercial experience till date, with moderate skin irritation being the most common side effect.
The US FDA determined that the TTFields delivery system for advanced liver cancer is a breakthrough technology, and is potentially more effective treatment for this condition.
Novocure is a global oncology company engaged in development and commercialisation of advanced TTFields therapy.
The company is currently studying TTFields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
