News

Advanced Accelerator Applications (AAA) Receives European Approval of Lutetium (177Lu) Oxodotreotide (Lutathera®) for Gastroenteropancreatic Neuroendocrine

AAA announced on September 29, 2017 that the European Commission (EC) has approved the marketing authorization of lutetium (177Lu) oxodotreotide* (Lutathera®) for “the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.” This approval allows for the marketing of lutetium (177Lu) oxodotreotide* (Lutathera®) in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein. A New Drug Application is currently under review by the US Food

AAA Opens Lutathera Expanded Access Program In U.S. to Eligible Patients And Announces Forthcoming NDA Filing to FDA and EMA.


AAA today announced that the company has initiated an expanded access program (EAP) in the United States for the investigational product, Lutathera. Through the program, Lutathera is being made available for patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy. Healthcare professionals and patients can learn more about the Lutathera EAP by visiting www.clinicaltrials.gov (trial number: NCT02705313). To read more visit AAA's website.

The results from the first randomized control trial of PRRT were released today in Vienna, Austria showing increased progression free survival compared to high dose octreotide LAR.

PRRT while available in many parts of the world has not yet been approved for use pending prospective randomized clinical trails (RCT). Having a positive RCT for PRRT will greatly expand access and availability to PRRT around the world. Click here to download the full release.

At the 2nd Theranostics World Congress there was progress towards the treatment of metastatic prostate cancer using a Theranostics approach. At the 3rd Theranostics World Congress that progress continued from the bench and to the bedside.

This video is an overview of the treatment and management of metastatic prostate cancer using a Theranostic Approach.

For the second year in a row, NorCal CarciNET Community and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) held a patient education day during the SNMMI's Annual Meeting. The program took place on June 8th and began with three (3) general lectures about the definition of nuclear medicine and molecular imaging, safety of nuclear medicine, the value of patient and physician partnerships in care management. The afternoon concluded with breakout sessions focused on hot topics in colon cancer, prostate cancer, thyroid diseases, and neuroendocrine tumors. The total number of attendees was 120 with over 50 attending the NET breakout. To see the complete program and recordings of the breakout sessions, visitwww.snmmi.org/PED. The NET sessions are available below.

Ga-68-labeled somatostatin analogs are important imaging agents to detect and manage neuroendocrine tumors (NETs). The SNMMI formed the 68Ga Users Group to advance the use of these imaging agents in the US. Members of the Users Group developed harmonized release criteria, an imaging manual, generic data collection forms and a draft informed consent form to aid the community in establishing investigator-sponsored trials. In October 2013, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) received orphan drug designation for Ga-68 DOTATOC.

BREAKING NEWS – the radiopharmaceutical Gallium-68 (DOTA0-hel-Tyr3) octreotide (Ga-68 DOTATOC) has been designated as an orphan drug by the US Food and Drug Administration (FDA) for the management of neuroendocrine tumors. This designation is significant because it may lead to faster approval of the agent, which would greatly benefit carcinoid/NET patients in the United States. Click here to read the full release the Society of Nuclear Medicine and Molecular Imaging and from

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