Transcript
“So the management of malignant glioma rests upon two main therapies. Temozolomide is FDA approved for the management of newly diagnosed glioblastoma and Avastin is after you’re approved for a recurrent glioblastoma. The literature that comes about to us using temozolomide actually was published in new England journal of medicine and led to the FDA approval of temozolomide for newly diagnosed glioblastoma. Avastin, recently, there were two main phase three studies that attempted to look at whether or not Avastin can be used in the newly diagnosed setting. Avastin is after you’re approved for the management of recurrent glioblastoma, based upon two small phase two studies. The phase three studies that looked at newly diagnosed glioblastoma in the use of Avastin, they really didn’t show any significant improvement in what we call overall survival. There was a thought that there may be some improvement of what we call progression free survival.
That is the time to the initial tumor growth after surgery has been undertaken. There also had been some concern as to whether or not the quality of life of individuals that received Avastin was either improved, stable, or actually declined. And the European and the United States phase three studies, there was a fair amount of contention regarding this issue. There are many non FDA approved therapies attempting to be evaluated for the management of malignant gliomas. Those includes agents that are vaccine driven, either made from the individual’s brain tumor itself or various proteins that are relevantly expressed on the glioblastoma that the vaccine is made and then given to the individual, or various what we call tyrosine kinase inhibitors, medications that actually target the intercellular relevant intracellular pathways that are inactivated or activated within malignant gliomas.”