NEWSLINE FDA Approves 18F- and 68Ga-DOTATATE Products

hrough its Priority Review mechanism, the U.S. Food of the prostate, a correct image finding was identified in Tand Drug Administration (FDA) recently approved an average of 90% of patients (range, 88%–93%). Results 2 products for use as diagnostic were affected by PSA levels, with a 31% rate of inaccurate PET agents. The first, approved on May 27, was Axumin interpretation in patients with PSA levels #1ng/mLand (18F-fluciclovine) injection, indicated for use in PET imag- a 16% rate of inaccurate interpretation in patients with PSA ing to identify suspected sites of recurrence levels .1ng/mL. in men with elevated levels of prostate-specific antigen 68Ga-DOTATATE in NETs (PSA) following prior treatment. The second, approved NETSPOT (Advanced Accelerator Applications SA on June 1, was the NETSPOT kit for preparation of 68Ga- [AAA]; Saint-Genis-Pouilly, France; previously marketed DOTATATE injection, indicated for localization of somato- as Somakit-TATE) is the first approved drug using 68Ga as a statin receptor–positive neuroendocrine tumors (NETs) in positron emitter. The 68Ga-DOTATATE kit received an Or- adult and pediatric patients. phan Drug designation from both the FDA and the European 18F-Fluciclovine in Recurrent Prostate Cancer Medicines Agency in March 2014. Although NETs have his- Axumin (Blue Earth Diagnostics Ltd.; Oxford, UK, and torically been considered as rare tumors, their incidence has Burlington, MA) is the first FDA-approved 18F-labeled PET grown .500% over the last 3 decades. agent for use in patients with suspected recurrent prostate AAA will commercialize the product in the United cancer. Axumin will be available through the national radio- States in 2 forms: as a kit for reconstitution using a 68Ga pharmacy network of the sole U.S. commercial manufacturer generator and as NETSPOT injection, a ready-to-use dose and distributor, Siemens PETNET Solutions (Malvern, PA). delivered from a local radiopharmacy in selected metropol- Initial commercial production of Axumin is underway at sev- itan areas. On June 9 and 10, AAA announced the selection eral regional radiopharmacies, and increasingly broader avail- of Cardinal Health, Inc. (Dublin, OH), Triad Isotopes, Inc. ability is planned in coming months. (Orlando, FL), and Nuclear Diagnostic Products, Inc. “An imaging agent with sufficient diagnostic perfor- (Plainview, NY) to supply 68Ga-DOTATATE doses prepared mance to adequately detect and localize recurrent prostate with the newly approved kit to U.S. hospitals and imaging cancer can provide referring physicians with actionable in- centers. NETSPOT is currently approved for use with the formation to guide biopsy and inform management deci- GalliaPharm 68Ga generator from Eckert and Ziegler (Berlin, sions for their patients,” said David M. Schuster, MD, an Germany). associate professor of Radiology and Imaging Sciences and “Use of advanced imaging techniques to detect rare director of the Division of Nuclear Medicine and Molecular NETs at an early stage in patients is critical,” said Libero Imaging at Emory University School of Medicine (Atlanta, Marzella, MD, PhD, director of the Division of Medical GA). The fluciclovine molecule in Axumin, originally de- Imaging Products in the FDA Center for Drug Evaluation veloped at Emory by Mark Goodman, PhD, detects upre- and Research. “NETSPOT provides another diagnostic tool gulation of transport that occurs in prostate whose results will help clinicians determine the location cancer, with the potential for identifying recurrent prostate and extent of the tumor. This information is important for cancer more reliably than conventional imaging techniques. planning the appropriate course of therapy.” “The product will be convenient for patients and imaging Three studies established the safety and effectiveness of facilities, as it can be made widely available, and the entire the product. The first compared 68Ga-DOTATATE PET im- imaging procedure can typically be completed in less than ages of NETs with images obtained with an approved drug, 30 minutes,” said Schuster. Blue Earth reported that the and then confirmed the results with CT or MR imaging. The fluciclovine molecule is currently being investigated for second compared 68Ga-DOTATATE PET imaging findings utility in other cancer indications, including glioma. with histopathology and clinical follow-up. The third In one of the studies used as part of the approval evaluated patients with NET recurrence using 68Ga- decision-making process by FDA, 18F-fluciclovine (also DOTATATE PET. known in the literature as trans-1-amino-3-18F-fluorocyclo- “NETSPOT has the potential to significantly improve butanecarboxylic acid or 18F-FACBC) images acquired in the accuracy of NET diagnosis while reducing radiation 105 patients were evaluated by 3 independent physicians exposure for patients,” said Stefano Buono, Chief Execu- who were unaware of the clinical details of each patient or tive Officer of AAA. “We believe that the use of NETSPOT whether the prostate biopsy was positive or negative. On should also offer increased comfort for patients by poten- average, a correct image finding was identified in 77% of tially shortening a procedure that is currently performed patients (range, 75%–79%). For cancer outside the region over 24 hours or more to just a few hours.”

Newsline 9N