The Tumor Treating Fields was included and recommended with Level 1 evidence as a treatment for GBM in China's Glioma Treatment Guideline
Novocure, along with its Chinese partner Zai Lab, a commercial stage biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Optune.
Novocure has developed a therapy for solid tumors called Tumor Treating Fields, and a delivery system Optune, for the treatment of cancers.
Optune uses electric fields tuned to required frequencies to disrupt cancer cell division, and inhibits tumour growth to cause death of the affected cancer cells, without stimulating or heating the tissue and targets.
Zai Lab founder and CEO Samantha Du said: “We are excited that Optune has been granted the Innovative Device Designation as it will allow our team to accelerate dialogue with the NMPA and bring us closer to commercializing Optune in China.
“Our launch in Hong Kong has provided valuable insight into the impact that this device can have on patients with GBM, which is an area of high unmet clinical need in China and globally. We look forward to working closely with the NMPA as Optune advances through the regulatory process in China.”
The Innovative Device Designation from China NMPA is expected to allow Zai Lab to accelerate the approval procedure for Optune.
In September 2018, Novocure granted Zai Lab an exclusive license for Tumor Treating Fields, including the brand name Optune, in Greater China. Zai Lab launched the product in Hong Kong for the treatment of glioblastoma (GBM) late last year.
Novocure markets Optune along with NovoTTF-100L System in US
Novocure markets Optune in the US, European Union, Japan and other countries for the treatment of GBM and the NovoTTF-100L System, another Tumor Treating Fields delivery system, in the US for the treatment of malignant pleural mesothelioma.
Its Tumor Treating Fields is in late stage clinical development for four solid tumour indications including non-small cell lung cancer, brain metastases, pancreatic and ovarian cancers.
Novocure executive chairman Bill Doyle said: “We are committed to bringing Optune to as many patients who may benefit as possible. Zai Lab has been an excellent partner as we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing Tumor Treating Fields therapy.
“We are pleased that together with our partners at Zai Lab we are one step closer to commercializing Optune in China.”