NovoCure Ltd. said the U.S. Food and Drug Administration approved its NovoTTF-100L System for use in combination with Eli Lilly and Co.'s Alimta and platinum-based chemotherapy as the initial treatment for tumors in a type of lung cancer.
The device in combination with Alimta plus platinum-based chemotherapy is now approved as the first-line treatment of malignant pleural mesothelioma that has grown outside the organ or has spread to other parts of the body and cannot be removed via surgery.
Malignant pleural mesothelioma is cancer that forms in the membrane around the lungs. The cancer has been strongly linked to asbestos exposure and is considered rare and aggressive.
According to the company's May 23 press release, this is the first treatment for malignant pleural mesothelioma approved by the FDA in over 15 years.
NovoTTF-100L System delivers tumor treating fields to the region of the tumor. Therapy with tumor-treating fields uses electric fields with specific frequencies to disrupt the tumor's cell division and inhibit tumor growth.
The FDA's approval is based on results from a phase 2 study, where the device in combination with chemotherapy improved survival in patients with the disease. The device was approved under the U.S. regulator's humanitarian device exemption process, which is used for devices that treat conditions affecting not more than 8,000 individuals in the U.S. per year.
Novocure markets another tumor treating field device named Optune to treat glioblastoma multiforme, the most common form of primary brain cancer.