China brings home a brain cancer treatment
Shanghai biopharma Zai Lab is bringing home its brain cancer therapy after the National Medical Products Administration approved Optune for treating patients with glioblastoma (GBM).
In-licensed from Novocure in 2018, Optune is approved in a number of foreign markets including the U.S., EU, and Japan. It is the first treatment for glioblastoma approved in China in over 15 years.
Also known as Tumor Treating Fields, Optune is a medical device that emits electrical fields tuned to specific frequencies that can disrupt cell division and inhibit tumor growth. “Although it's a device, the way it's developed and the way it will be commercialized, it's more like a therapeutic,” Jonathan Wang, Zai Lab’s senior vice president, head of business development, told STAT.
According to Wang, Optune’s innovative medical device designation, as well as approvals in other markets based on global clinical data, expedited the therapy’s approval time to just eight months; Chinese regulators waived the local clinical trial requirement.
“There’s a lot of KOL support and a lot of real world patient data that really helped to convince the NMPA that this is a very transformative technology for a patient population” that doesn’t have many options, said Wang.
In China, more than 45,000 patients are diagnosed with GBM every year. Chemotherapy temozolomide was the only drug approved to treat the disease in China.
In-licensed from Novocure in 2018, Optune is approved in a number of foreign markets including the U.S., EU, and Japan. It is the first treatment for glioblastoma approved in China in over 15 years.
Also known as Tumor Treating Fields, Optune is a medical device that emits electrical fields tuned to specific frequencies that can disrupt cell division and inhibit tumor growth. “Although it's a device, the way it's developed and the way it will be commercialized, it's more like a therapeutic,” Jonathan Wang, Zai Lab’s senior vice president, head of business development, told STAT.
According to Wang, Optune’s innovative medical device designation, as well as approvals in other markets based on global clinical data, expedited the therapy’s approval time to just eight months; Chinese regulators waived the local clinical trial requirement.
“There’s a lot of KOL support and a lot of real world patient data that really helped to convince the NMPA that this is a very transformative technology for a patient population” that doesn’t have many options, said Wang.
In China, more than 45,000 patients are diagnosed with GBM every year. Chemotherapy temozolomide was the only drug approved to treat the disease in China.
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