FDA Grants Breakthrough Device Designation to the NovoTTF-200T™ System for Advanced Liver Cancer

Rhea-AI Summary

Novocure (NASDAQ: NVCR) announced that the U.S. FDA granted breakthrough designation for its NovoTTF-200T System to treat advanced liver cancer in combination with atezolizumab and bevacizumab. This designation allows Novocure to engage closely with FDA experts during the regulatory review process. The breakthrough status is supported by clinical data from the phase 2 pilot HEPANOVA trial, indicating TTFields may extend survival in patients with unresectable liver cancer. However, TTFields' use for this indication remains investigational.

Positive

• FDA granted breakthrough designation for NovoTTF-200T System for advanced liver cancer treatment.
• Allows prioritized regulatory review and interaction with FDA experts.
• Potential to improve survival rates in a life-threatening condition.

Negative

• TTFields utilization in liver cancer treatment remains investigational.

NovoTTF-200T is a Tumor Treating Fields delivery system intended for use together with atezolizumab and bevacizumab for the treatment of patients with advanced liver cancer

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced 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. 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.

The U.S. FDA has granted breakthrough device designation to Novocure's NovoTTF-200T™ System for advanced liver cancer. (Photo: Business Wire)

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.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields (TTFields). TTFields are electric fields that disrupt cancer cell division. Novocure’s commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating TTFields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about us, visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 25, 2021 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210909005551/en/

Investors:

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427

Media:

Leigh Labrie

media@novocure.com

610-723-7428

Source: Novocure

FAQ

What recent FDA designation did Novocure receive for NVCR?

Novocure received a breakthrough designation for its NovoTTF-200T System for the treatment of advanced liver cancer.

What is the NovoTTF-200T System used for?

The NovoTTF-200T System is intended for treating advanced liver cancer in conjunction with atezolizumab and bevacizumab.

What does breakthrough designation mean for Novocure?

It provides Novocure with expedited regulatory review and closer collaboration with FDA experts.

What trial data supported the FDA's decision for Novocure?

The FDA's decision was based on clinical data from the phase 2 pilot HEPANOVA trial.

Is the NovoTTF-200T System currently approved for liver cancer treatment?

No, the use of the NovoTTF-200T System for liver cancer treatment is still investigational.