Novocure, a commercial stage oncology company, announced today that it has submitted the registration dossier for Pre-Market Approval (PMA) of the NovoTTF-100A System to treat recurrent glioblastoma to the Japanese Pharmaceutical and Medical Device Agency (PMDA).
Glioblastoma is the most common and deadly form of primary brain cancer. The disease is known as recurrent glioblastoma when the tumor progresses or recurs after initial treatment.
"Over the last year, we have been working very closely with the MHLW and PMDA officials in preparation for our filing," said Asaf Danziger, Chief Executive Officer of Novocure. "Given the high unmet medical need for new therapies in recurrent glioblastoma, we will continue to work closely with the regulatory authorities to bring NovoTTF Therapy to Japanese patients as quickly as possible.
We will also continue to support compassionate use requests from certified physicians for patients with recurrent glioblastoma while we await regulatory approval."
"We believe that NovoTTF Therapy is an important new treatment option for patients with recurrent glioblastoma," said Ryo Nishikawa, MD, Ph.D., Vice President of the Japanese Society of Neuro-Oncology, and Professor, Department of Neurosurgery, Saitama International Medical Center, Saitama Medical University. "We respectfully ask that the MHLW look favorably at the filing and accelerate approval for our patients in need of new options."
"I believe that NovoTTF Therapy can offer a real benefit to Japanese patients given its demonstrated efficacy and unique safety and quality-of-life profile," said Masao Matsutani, MD, Ph.D, Honorary Member of the Japanese Society of Neuro-Oncology, and Professor Emeritus, Saitama Medical University.
"Patients with recurrent glioblastoma have very few effective therapeutic options and many cannot tolerate the severe systemic side effects associated with traditional chemotherapies."