Novocure Earns CE Mark for NovoTTF-100L System

Novocure, a global oncology company working to extend survival in some of the most aggressive forms of cancer, 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.”