Approval speed up! Tumor electric field therapy was qualified as an innovative medical device.

(Health Times reporter Ko Xiaoxuan)
. Recently, Reding Pharmaceuticals and Novocure announced that The State Drug Administration of China has awarded Optune, a cancer field treatment product, ® innovative medical device qualification, and the time to market in China is expected to be shortened.
"glioblastoma is one of the most difficult refractive tumors in neurosurgery, with a recurrence rate of almost 100%. All we can do now is to alleviate the disease as much as possible and prolong the patient's life under the premise of ensuring the quality of life of patients," said Professor Mao Ying, vice president of Huashan Hospital affiliated with Fudan University and executive vice president of neurosurgery. Professor Jiang Tao, deputy director of the Institute of Neurosurgery at Beijing
and deputy director of neurosurgery at Beijing Tiantan Hospital, said the average median survival of glioblastoma patients is about 15 months, with a 5-year survival rate of only 5% to 6%. The international phase III clinical results of tumor electro-field therapy showed that compared to the treatment of dimozole alone, the electric field therapy and the combination of dimomyone were used to treat new glioblastoma, and the median total survival of patients was extended to 20.9 months, and 13% of patients could survive for more than 5 years. "Patients' desire for life can be extended, and new treatments offer new hope, " says Professor Jiang Tao."At present, at the policy level, the state supports medical device innovation, putting both device innovation and drug innovation in a very important position, "
. I believe that there will be a lot of innovative equipment coming out soon. The government has given policy impetus, and the inclusion of tumor field therapy in the National Special Review Channel for Innovative Medical Devices is a good example; Professor Mao Ying said.
it is understood that the tumor electric field treatment product Optune ® has been approved by the FDA in 2011 and 2015 for the treatment of patients with relapsed and newly diagnosed glioblastoma, is currently the world's first and only FDA approved tumor electric field treatment products, has been approved in the United States, Europe, Japan and other countries and regions for the treatment of glioblastoma.
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