Optune?, a therapeutic treatment that delivers tumor treating fields (TTFields), is a novel cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division leading to inhibition of tumor growth death of tumor cells.
Optune? is currently marketed in the United States, the European Union, Switzerland, Japan, Mainland China, Hong Kong (China) and certain other countries/areas for the treatment of newly diagnosed or recurrent GBM. It is also in advanced clinical development for multiple additional solid tumor indications. In multiple clinical trials, TTFields demonstrated marked efficacy results and safety profile in NSCLC, pancreatic cancer and malignant mesothelioma.
In September 2018, we obtained an exclusive license to commercialize Optune? in mainland China, Hong Kong (China), Macau (China) and Taiwan region from Novocure, Inc. In addition to GBM, we will collaborate with Novocure on development activities for TTFields in multiple solid tumor indications. Since Dec. 2018, Optune? has been available in Hong Kong (China) for the treatment of glioblastoma multiforme (GBM). Hong Kong is the fourth market after the United States, the European and Japan to have access to this important new medical technology. In May 2020, the China National Medical Products Administration (NMPA) approved the Marketing Authorization Application (MAA) for Optune? in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM.
Mechanism of Action
TTFields is a novel technology platform developed for cancer therapy. It uses alternating electric fields tuned to specific frequencies to target cancer cells by disrupting cell division, inhibiting tumor growth and causing affected cancer cells to die. The electric fields have impact on highly charged and polar proteins such as tubulin and septin which are critical for normal cell division (mitosis). During normal cell division, tubulin and septin must position themselves in a particular way in order for the cell to divide. TTFields exerts forces on tubulin and septin, preventing them from moving to their correct locations leading to disruption of cancer cell division. At the specific frequency tested, TTFields do not seem to affect healthy cells. Mild to moderate skin irritation is the most common side effect reported.