Advanced Accelerator Applications, an emerging international leader in molecular nuclear medicine, has received GMP approval for the manufacture of Lutathera®, a radioactively labelled peptide that can be used to treat metastatic GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs).
The approval by the Italian Pharmaceutical Regulatory Authority will enable AAA to manufacture Lutathera® at its facility in Colleretto Giacosa, near Turin, Italy, making it the first industrial facility in the world approved to produce radio-labelled peptides for molecular nuclear therapy.
Lutathera® has been shown to be an effective and safe treatment for GEP-NETs in an investigator-sponsored clinical study at the Erasmus Medical Center, Rotterdam, Netherlands, where over 600 patients have been treated with this innovative radiopharmaceutical. The study showed Lutathera® extended patients’ lives by between 3.5 and six years in comparison to current treatments, including chemotherapy. It was also shown to significantly improve quality of life, as measured by a number of function and symptom scales, especially in patients with proven tumor regression.
The US FDA and the EMEA have indicated the need for a Phase III study in order to prepare Lutate for registration. AAA has started a Parallel Scientific Advice from the EMEA and FDA to discuss its Phase III protocol. The PSA system was introduced in 2006 to allow both agencies to exchange scientific views during the development phase of new drugs. AAA hopes to start a multicenter Phase III study in 2011 in both Europe and the United States, with potential approval anticipated in 2015. Lutathera®has been granted Orphan Drug status by both the FDA and EMEA.
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