Optune Lua, formerly known as NovoTTF-100L, is the first FDA-approved treatment for malignant pleural mesothelioma in over 15 years
Novocure (NASDAQ: NVCR) announced today that Optune Lua is the brand name for the NovoTTF-100L System in malignant pleural mesothelioma (MPM). The U.S. Food and Drug Administration (FDA) previously approved Novocure’s Tumor Treating Fields delivery system concurrent with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic MPM.
“The Optune brand emphasizes the unique product offerings of Novocure’s Tumor Treating Fields delivery systems and suggests the prospect of hope and optimized care,” said Pritesh Shah, Novocure’s Chief Commercial Officer. “Optune Lua is easy to pronounce and remember, and should help patients, caregivers and providers ask for the treatment by name.”
With the FDA’s approval of the Optune Lua brand name, all of Novocure’s Tumor Treating Fields delivery systems are aligned under a single brand family, Optune. The addition of a suffix to the Optune brand name helps differentiate between Tumor Treating Fields delivery systems for the treatment of MPM, glioblastoma and future potential indications.
About Optune Lua
Optune Lua is a noninvasive, antimitotic cancer treatment for MPM. Optune Lua delivers Tumor Treating Fields to the region of the tumor.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. 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 in the U.S. 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
Approved Indications
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
Contraindications
Do not use Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of Optune Lua together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with 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
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 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 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 Optune Lua treatment.
Do not prescribe Optune Lua for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Lua in these populations have not been established.
Please visit www.optunelua.com to see Optune Lua Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.
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. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with 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, liver cancer and gastric 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.
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, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Report on Form 10-K filed on February 27, 2020, 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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