Zai Lab Ltd (Nasdaq: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy for recurrent glioblastoma. Optune is recognized as the sole glioblastoma therapy to gain approval in China over the past 15 years, marking a significant advancement in the country’s oncology landscape.
With an annual incidence of 45,000 new glioblastoma cases, China faces a substantial clinical need due to the scarcity of effective treatment options. Optune is a portable, non-invasive device that applies TTF, utilizing electric fields at specific frequencies to disrupt cancer cell division, inhibit tumor growth, and induce cell death. Globally, Optune has already treated over 15,000 glioblastoma patients. The device’s inclusion in the 2018 gliomas diagnosis and treatment standards by the National Health Commission (NHC) as level 1 evidence underscores its clinical significance.
Optune has also received approval from the US Food and Drug Administration (FDA) under the Humanitarian Device Exemption (HDE) for the treatment of malignant pleural mesothelioma (MPM), with plans to file for the same indication in China shortly. The device is currently in development for additional applications, including brain metastasis, non-small cell lung cancer, pancreatic cancer, and ovarian cancer.
