Novocure’s Optune has became the first innovative treatment for glioblastoma approved in China in over 15 years, the company said in a Wednesday press release, after it’s global phase 3 pivotal clinical study in newly diagnosed glioblastoma showed adding Optune to chemotherapy more than doubled the five-year overall survival rate.
ST. HELIER, Jersey & SHANGHAI–(BUSINESS WIRE)–#btsm–Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform therapy called Tumor Treating Fields, and Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has 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. GBM is the most common form of primary brain cancer, and Optune is the first treatment for glioblastoma approved in China in over 15 years.
“The NMPA’s approval of Optune is a significant treatment advance for GBM patients in China and another important milestone for Zai,” said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. “Optune was previously granted the Innovative Medical Device Designation, which highlights the differentiation and importance of this novel treatment for GBM patients. We appreciate the NMPA for their partnership through this rapid and thorough assessment of the Optune application, recognizing the high unmet medical need it serves. We look forward to working with Novocure to bring Tumor Treating Fields to GBM and other difficult to treat cancer indications.”
“Novocure is working to extend survival in some of the most aggressive cancers through the development and commercialization of Tumor Treating Fields,” said William Doyle, Novocure’s Executive Chairman. “Approval of Optune for GBM in Greater China extends the promise of Tumor Treating Fields therapy to patients in the world’s largest market. We thank Zai Lab for their commitment and hard work and congratulate them on their second product approval in six months.”
Optune delivers Tumor Treating Fields therapy to the region of the tumor. Globally, more than 15,000 GBM patients have been treated with Optune, to date. Tumor Treating Fields is also approved by the U.S. FDA under the Humanitarian Device Exemption pathway for the treatment of malignant pleural mesothelioma (MPM), which is anticipated to be the next MAA filed with the NMPA. In addition to GBM and MPM, Tumor Treating Fields is under evaluation in global phase 3 pivotal trials for the treatment of brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer, and in phase 2 pilot trials for liver cancer and gastric cancer. Approximately 1.5 million patients a year in China are diagnosed with non-small cell lung cancer, pancreatic cancer, ovarian cancer and gastric cancer, collectively.
“In China, there are more than 45,000 patients diagnosed with GBM each year and this approval marks the first new treatment option for these patients in over 15 years,” said Jiang Tao, M.D., Ph.D., Head of Beijing Neurosurgical Institute, Founder of Chinese Glioma Genome Atlas, and Professor of Beijing Tiantan Hospital. “Optune was recommended with Level 1 evidence as a treatment for newly diagnosed GBM patients in China’s Glioma Treatment Guideline in 2018, and we are excited to now have Optune available as part of the standard of care for GBM patients in China.”