Published May, 2017

Dear Tumor Section Executive Committee colleagues,
I'm thrilled to share with you some exciting news. Today, in Washington DC, Dr. Costas Hadjipanayis and I had the honor of testifying before the Food and Drug Administration Medical Imaging Drugs Advisory Committee in support of the use of 5-ALA as an imaging agent, to facilitate the real time detection and visualization of malignant tissue during glioma surgery. Costas served as the lead study investigator and has been working tirelessly for many years, along with Walter Stummer from Germany, to provide evidenced based support for the use of 5-ALA in the United States. In fact, many of us in the tumor section participated in training sessions and the multi-institutional clinical trial now being led by Isabelle Germano, to study the efficacy and positive predictive value of 5-ALA. I was extremely proud to represent our Section today; the FDA panel has great respect for neurosurgeons and brain tumor specialists in particular and they clearly put forth a considerable effort in grappling with a complex subject in order to expand our surgical armamentarium in the ongoing fight against malignant brain tumors. In a rather unusual step, the advisory committee voted unanimously 11-0 in favor of this proposal to recommend 5-ALA approval with a broad indication for "glioma surgery" to the FDA.  Official FDA endorsement is expected within the next 6 weeks. Congratulations Costas, Isabelle and to all of you who participated in the 5-ALA journey over the last several years.

Steven Kalkanis MD
Chair, Section on Tumors