FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma This is great news. Hopefully the FDA will quickly approve the Optune system for newly diagnosed GBM patients. Right now it is only approved for recurrent GBM patients but with results like this ( a 48% increase in 2 year survival rate), of course newly diagnosed patients should be using it.
Newly diagnosed patients can use it now off label. I just had a patient request my help in fighting his insurance company - they rejected the claim for Optune for his newly diagnosed GBM saying it is experimental for newly diagnosed. I sent a nice letter along with the research and they reversed the decision, saying they will now pay for it. Getting the FDA - then the NCCN - to support it's use for newly diagnosed will speed things up and avoid that problem.
