Novocure-Zai announce MAA approval for Optune to treat GBM patients

Novocure and Zai Lab Ltd. have recently announced the MAA (Marketing Authorization Application) approval from the China NMPA (National Medical Products Administration). The approval has been given for the use of Optune, in combination with temozolomide, to treat newly diagnosed GBM (glioblastoma) patients. It will also be used as a monotherapy for patients suffering from recurrent GBM. Optune is the 1st treatment for GBM that has been approved in over 15 years in China.

According to Dr. Samantha Du, Zai Lab’s CEO, Chairperson, and Founder, the recent approval is a significant treatment advancement for GBM patients in China and an important milestone for the company. Optune has previously been granted with the Innovative Medical Device Designation. It highlights the importance and differentiation of this novel treatment for patients with GBM. The company appreciates NMPA for this thorough and rapid assessment of the application of Optune, which will help serve high unmet medical needs. Dr. Du further stated that the company is looking forward to working with Novocure, to leverage Tumor Treating Fields and treat several cancer indications, including GBM.

William Doyle, Executive Chairman of Novocure, stated that the company is focusing on the commercialization and development of Tumor Treating Fields to increase the survival rate of several aggressive cancers. He also expressed appreciation towards their partner, Zai Lab, for collectively working to obtain Optune approval in Greater China.

Tumor Treating Fields therapy is delivered by Optune to the tumor region. It has been used to treat over 15,000 GBM patients to date, globally. The therapy has been approved by the FDA for the treatment of MPM (malignant pleural mesothelioma), which is expected to be the next Marketing Authorization Application filed with the China NMPA. It is also under Phase 3 pivotal trials to treat ovarian cancer, pancreatic cancer, non-small cell lung cancer, and brain metastases, and in Phase 2 pilot trials to treat gastric cancer and liver cancer. In China, over 1.5 million patients are diagnosed with gastric, ovarian, non-small cell lung, and pancreatic cancers, collectively in a year.

Source credit:https://www.businesswire.com/news/home/20200513005458/en/China-NMPA-Approves-Optune%C2%AE-Treatment-Newly-Diagnosed