The regulatory approval in the European Union comes approximately six months after Novocure secured FDA approval of the system, which uses tumor-treating fields (TTFields) to kill cancer cells. Through non-invasive, wearable arrays, Optune Lua uses TTFields to exert physical forces on the electrically charged components of the dividing cancer cells.
“Optune Lua is an innovative and urgently needed new approach for treating metastatic non-small cell lung cancer,” Dr. Joachim Aerts, an investigator in the system’s Phase 3 LUNAR clinical trial and professor of pulmonary oncology at the Erasmus MC Cancer Institute.
“There are few treatment options for people living with this aggressive cancer,” Aerts said in the news release. “In fact, the results from the Phase 3 trial of Optune Lua were the first in more than eight years to show a treatment providing a significant extension in overall survival. These results and the lack of systemic toxicity observed with Optune Lua provide patients with a promising new treatment option.”
Frank Leonard, president of Novocure Oncology, described the CE mark as a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers.
“Tumor Treating Fields therapy has demonstrated effectiveness in multiple tumor types that have historically been very difficult to treat, including lung cancer. We believe the efficacy Optune Lua can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated,” Leonard said.
Novocure has initiated the local registration requirements for Optune Lua in Germany and is set to launch the system in the coming weeks.
Read more about Novocure in Medical Design & Outsourcing: Leveraging biophysics to fight the most aggressive forms of cancer
