FDA Approves Second Generation Optune System for Glioblastoma Treatment
The FDA approved the 2nd generation Optune System, which is intended for the treatment of glioblastoma.
The U.S. Food and Drug Administration (FDA) approved Novocure's premarket approval (PMA) supplement application for the second generation Optune System, which is intended for the treatment of glioblastoma.1
This Tumor Treating Fields (TTFields) delivery system is smaller and lighter than the first generation model, making treatment with TTFields more convenient and manageable for patients.
Improvements to the Optune System include easy-grip texture that improves handling of the device, a light-detecting sensor that auto-dims the device and charger in the dark, and a “No-Stop Swap” feature that allows patients to change batteries or power source without disrupting TTFields therapy delivery.
Patients with the first generation system will have the opportunity to switch to the second generation Optune System, while all new patients with receive the second generation TTFields delivery device.
"We believe the improvements incorporated into the second generation Optune system will make a big difference to the patients and families who face this devastating disease," said Asaf Danziger, Novocure's Chief Executive Officer. "We will continue to work to improve our technology and patient experience."
The first generation Optune System was approved in October 2015 for the treatment of patients aged 22 years or older with histologically-confirmed glioblastoma multiforme. It is indicated, in conjunction with temozolomide, for adult patients with newly diagnosed supratentorial glioblastoma, following maximal debulking surgery and completion of radiotherapy together, in addition to standard chemotherapy.
Optune can be used as monotherapy for the treatment of recurrent glioblastoma in the supratentorial region of the brain, though only after receiving chemotherapy.
- Novocure receives FDA approval for second generation Optune System [news release]. http://www.businesswire.com/news/home/20160713006423/en/. Updated July 13, 2016. Accessed July 15, 2016.