Novocure and ZaiLab’s Optune Receive NMPA’s Approval for the Treatment of Newly Diagnosed and Recurrent Glioblastoma
Novocure and ZaiLab’s Optune Receive NMPA’s Approval for the Treatment of Newly Diagnosed and Recurrent Glioblastoma
Shots:
- The NMPS has approved the combination of MAA for Optune + temozolomide to treat patients with newly diagnosed GBM and a monothx. for patients with recurrent GBM. The P-III study in newly diagnosed GBM showed adding Optune to CT more than doubled the 5yrs. OS rate
- Tumor Treating Fields therapy receives the US FDA’s approval under the Humanitarian Device Exemption pathway for MPM and is anticipated to be the next MAA filed to NMPA. In addition to GBM and MPM, Tumor Treating Fields is being evaluated in P-III study for brain metastases, NSCLC, pancreatic cancer and ovarian cancer & P-II for liver cancer and gastric cancer
- Optune is a noninvasive, antimitotic cancer treatment for GBM, delivers Tumor Treating Fields to the region of the tumor and has received NMPA’s the Innovative Medical Device Designation
Click here to read full press release/ article | Ref: Businesswire | Image: Novocure