On May 28, the Food and Drug Administration approved 18F-flortaucipir, also known as AV1451, under the trademark name Tauvid (Avid Radiopharmaceuticals), for estimation of the density and distribution of aggregated tau neurofibrillary tangles in adults with cognitive impairment who are being evaluated for Alzheimer disease (AD). As such, 18F-flortaucipir is the first approved tau PET tracer. This is a great achievement and a major step forward in our mission to improve AD diagnosis. AD is histopathologically characterized by the presence of b-amyloid plaques and neurofibrillary tangles in the brain. To detect amyloid pathology in vivo, several PET tracers are approved. Establishment of cerebral tau pathology, however, has been possible so far only by experimental PET tracers or after death via histopathologic examination. We now have the opportunity to shift this important event into the clinic—that is, to a time point at which the tau diagnosis might influence patient management.

18F-flortaucipir was developed as 18F-T807 and successfully brought to human use in 2012 by Hartmuth Kolb’s group at Siemens Healthcare (1). In 2013, the rights were acquired by Avid. The recent Food and Drug Administration approval of this tracer was based on positive tracer safety data as obtained in more than 1,900 subjects, and on a successful pivotal phase 3 program. In the latter, in vivo PET imaging was compared in 2 trials, intraindividually, with postmortem histopathology, and favorable results were recently published in JAMA Neurology (2). The editorial by Mattay et al.(3) in this issue of The Journal of Nuclear Medicine provides more insight into the Food and Drug Administration’s perspective on the filed data and the approval. I am taking the chance here to add my perspective as a brain PET scientist to this new, exciting development.