Radioactive Somatostatin Analog Under Review by FDA (Again) to Treat Neuroendocrine Tumors
AUGUST 28, 2017
The U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for lutetium (177Lu) oxodotreotide (Lutathera), a radiolabeled somatostatin analog to treat adults with unresectable or metastatic, progressive, well differentiated, somatostatin receptor positive neuroendocrine tumors (NETs).
The FDA provided a new Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.
NETs are a rare type of cancer that originate in neuroendocrine cells throughout the body, and are most often found in the gastrointestinal tract, lungs or pancreas. NETs often have somatostatin receptors on them and last year, the FDA approved a radioactive probe to assist in the location of NETs in the body. In contrast, Lutathera would be used treat those somatostatin containing tumors.
The NDA resubmission follows a Complete Response Letter from the FDA in December 2016 citing issues with the format, traceability, uniformity, and completeness relating to the clinical datasets presented.The Complete Response Letter also requested subgroup analyses for gender, age and race, as well as a safety update from both clinical and non-clinical studies.
Lutathera, the 177-Lu labeled somatostatin analog, is a new form of targeted therapy in which the radiolabeled drug binds to somatostatin receptors present in GEN-NETs.
At the 2015 North American Neuroendocrine Tumor Society (NANETS) Annual Symposium in Austin, Texas, we talked with Jonathan R. Strosberg, MD, medical oncologist, Department of Gastrointestinal Oncology at the Moffitt Cancer Center about the phase 3 NETTER-1 trial for midgut NETs that is part of the NLA submission.
Lutathera is being developed byAdvanced Accelerator Applications (AAA), a France based radiopharmaceutical company.
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