Novocure Announces FDA Approval of an IDE Supplement Allowing All Control Patients in its Phase III Trial in Newly Diagnosed GBM to Cross Over to Receive Tumor Treating Fields
This is amazing - that the FDA has moved so quickly. The data from this trial was released less than 3 weeks ago and the FDA has already acted on it.
(As far as I know) This was the first time in history that the FDA allowed a brain tumor trial to stop the control group and move them into the active treatment group because the results were so good in the control group that it is unethical to continue a contril group!
Posted on: 12/02/2014
Based on the results of the trial's pre-specified interim analysis all control patients in the EF-14 phase III trial will be offered the opportunity to cross over to receive Tumor Treating Fields
New York, NY – December 2, 2014 – Novocure announced today that the United States Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement allowing all control patients in the EF-14 Phase III trial in newly diagnosed glioblastoma (GBM) to receive tumor treating fields (TTFields) delivered by the NovoTTF-100A System. The IDE supplement approval is based on the results of the trial's pre-specified interim analysis of overall survival and progression free survival and the subsequent recommendations of the trial's independent data monitoring committee (DMC) that the trial be terminated early for success and that all control patients be offered tumor treating fields therapy even prior to progression.
"We are pleased the FDA has granted this approval so quickly," said Dr. Roger Stupp, M.D., Director of the University Hospital Cancer Center the University of Zurich, Switzerland and EF-14 Principal Investigator. "Allowing the control patients to receive TTFields immediately is an ethical obligation considering the results of the interim analysis of the trial."
"We are working closely with the trial sites, institutional review boards and local health authorities to implement patient cross over to the TTFields arm of the study," said Uri Weinberg, M.D, Ph.D., Vice President for Research and Development at Novocure. "It is a rare and exciting event to be able to offer the active investigational treatment to patients who were randomized to the control arm of a trial."
"The FDA was extremely responsive in working with Novocure towards this IDE approval, given the exceptional circumstances presented. We are looking forward to continuing to work closely with the FDA to obtain marketing approval for TTFields therapy in patients with newly diagnosed GBM as expeditiously as possible," said Asaf Danziger, Novocure's Chief Executive Officer.
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