FDA Approves Novocure's Second-Generation Optune System
Novocure has announced that the FDA has okayed its premarket approval (PMA) supplement application for the company’s second-generation Tumor Treating Fields (TTFields) technology, Optune. The system — which uses alternating electric fields to slow tumor growth rate — is now smaller and lighter than its previous generation, making it more convenient for patients’ personal use.
The Optune system is indicated for adult patients newly diagnosed with glioblastoma, used in conjunction with temozolomide, an oral chemotherapy medication. Ceramic disks attached to the scalp in close proximity to the tumor deliver low intensity, intermediate frequency, alternating electrical fields into the brain, which research shows can halt the cancer’s cell division and proliferation. The battery-operated device is worn by the patient 18 hours a day for at least four weeks, according to the American Brain Tumor Association (ABTA).
The device was first introduced in 2007, and the technology — then known as Novo-TFF — was approved by the FDA in 2011 for cases of glioblastoma that have recurred after a patient has received chemotherapy or radiation.
In October, Novocure announced the FDA’s PMA approval of Optune for newly diagnosed patients, reporting that patients receiving therapy alongside medication showed a survival rate improved by 50 percent. Results from the phase III trial were so successful that the company received permission from an independent data-monitoring committee to submit an application to the FDA before the trial had concluded, said the company in a statement.
With the incorporation of “novel digital signal generation technology,” Novocure was able to make its TTFields system smaller, and the second-generation Optune is 2.7 pounds, compared to the 6 pound first-generation device, according to a press release. Other improvements include a better grip, battery life sensors, and a feature that allows patients to change batteries without disrupting treatment.
Over the next few weeks, Novocure intends to allow existing patients using Optune to switch to the second-generation device, and all patients trying Optune for the first time will receive the newer model. Novocure CEO Azaf Danziger remarked that the company will continue to improve the technology to maximize patient experience.
“From the start, Novocure’s mission has been to improve the lives of cancer patients,” said Mike Ambrogi, Novocure’s COO, noting positive feedback from patients in Europe and Novocure’s eagerness to introduce the new system to patients in the U.S. “The second generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives.”
Glioblastoma multiforme accounts for 52 percent of all primary brain tumors and typically results in death within the first 15 months following diagnosis, according to the American Association of Neurological Surgeons. Forbes estimated that the 10,000 new cases of glioblastoma per year could generate over $1 billion in profits per year for Novocure within three years.
Novocure currently is conducting phase II and III trials to investigate TTFields efficacy with other challenging cancers, such as ovarian, small-cell lung, mesothelioma, and pancreatic cancers.