Novocure today announced that the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100A System (NovoTTF) for the treatment of adult patients with glioblastoma multiforme (GBM) brain tumors, following tumor recurrence after receiving chemotherapy. The portable, wearable device delivers an anti-mitotic, anti-cancer therapy as patients maintain their normal daily activities. The NovoTTF is a novel, first-in-class treatment option for patients and physicians battling glioblastoma.
"Our device provides patients and physicians with a novel, non-invasive alternative to chemotherapy that is safe and effective," said Eilon Kirson, M.D., Ph.D., Novocure's Chief Medical Officer. "The device allows for continuous treatment without the usual, debilitating side effects that chemotherapies inflict on recurrent GBM patients and indirectly on their families."
Results from a 237 patient randomized pivotal trial demonstrated that compared to patients treated with chemotherapy, NovoTTF treated patients achieved comparable median overall survival times, had fewer side effects, and reported improved quality of life scores.
Glioblastoma is the most aggressive and most common form of primary brain tumor in the United States. The disease affects approximately 10,000 Americans each year. The median overall survival time from initial diagnosis is 15 months with optimal therapy, and median survival from the time of tumor recurrence is only three to four months without additional effective treatment. The disease is widely recognized as one of the most aggressive and deadly forms of cancer.
"We move forward from today proud of the efforts and accomplishments of our team, thankful to our investors for their support and guidance, and humbled by the trust of our patients and physicians," said Asaf Danziger, CEO of Novocure. "Our next task is to make NovoTTF therapy available as a treatment option for all recurrent GBM patients in the U.S."
"The FDA approval of the NovoTTF device is the culmination of ten years of research, development and clinical trials conducted by an exceptional team of scientists, engineers, and clinicians and built on the original insights of our founder and CTO Yoram Palti, M.D., Ph.D.," said William F. Doyle, Novocure's executive chairman. "We look forward to bringing this device to recurrent GBM patients and their families, and we look forward to developing NovoTTF therapy for a range of additional solid tumor cancers."
Pivotal Trial Results