Novocure (NASDAQ: NVCR), a global oncology company working to extend survival in some of the most aggressive forms of cancer, today announced that it has received the CE Mark for the NovoTTF-100L system from the Notified Body (TÜV). The application of the CE mark enables Novocure to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) in the European Union and Switzerland.
MPM is a rare cancer that has been strongly linked to asbestos exposure. More than 13,000 people are diagnosed with mesothelioma in Europe annually. The U.S. FDA approved the NovoTTF-100L System (known as Optune Lua™ in the U.S.) as a treatment for MPM in May 2019 under the Humanitarian Device Exemption (HDE) pathway. Optune Lua was the first treatment for MPM approved by the FDA in more than 15 years. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM. Now having the CE mark for its MPM therapy in Europe, Novocure will begin commercialization and to identify and pursue pathways for reimbursement in selected markets.
“We are extremely pleased to have CE marking for our NovoTTF-100L System, making our therapy commercially available for patients with MPM in Europe,” said Pritesh Shah, Novocure’s Chief Commercial Officer. “Obtaining the CE mark for our NovoTTF-100L System represents another step forward on our patient-forward mission of striving to extend survival in some of the most aggressive forms of cancer. Our commercial team in EMEA is now focused on establishing pathways for reimbursement to expand access to our therapy for MPM patients.”
NovoTTF-100L is a noninvasive, antimitotic cancer treatment for MPM. NovoTTF-100L delivers Tumor Treating Fields, which is a cancer therapy using electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.
Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.
NovoTTF-100L/Optune Lua is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.
Important Safety Information
Do not use NovoTTF-100L/Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of NovoTTF-100L/Optune Lua together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Do not use NovoTTF-100L/Optune Lua in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with NovoTTF-100L/Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions
NovoTTF-100L/Optune Lua can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure®.
The most common (≥10%) adverse events involving NovoTTF-100L/Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.
Other potential adverse effects associated with the use of NovoTTF-100L/Optune Lua include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.
If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with NovoTTF-100L/Optune Lua treatment.
Do not prescribe NovoTTF-100L/Optune Lua for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of NovoTTF-100L/Optune Lua in these populations have not been established.
Please visit www.optunelua.com to see NovoTTF-100L/Optune Lua Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions. This website is primarily intended for a U.S. audience.
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. Tumor Treating Fields therapy uses electric fields to 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 Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver 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 the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
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, 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 27, 2020 and its Quarterly Report on Form 10-Q filed on April 30, 2020, as amended to date, 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.
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