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FDA accepts resubmitted application for Lutathera to treat neuroendocrine tumors
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The FDA accepted the resubmission of a new drug application for lutetium Lu 177 dotatate for treatment of adults with unresectable or metastatic, progressive, well-differentiated, somatostatin receptor-positive neuroendocrine tumors.
Lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) is a somatostatin analog peptide designed to target tumors with radiolabeled molecules that bind to specific receptors expressed by the tumor.
The company previously submitted a new drug application, but the FDA issued a complete response letter in December 2016 that cited issues with the format, traceability, uniformity and completeness relating to the NETTER-1 and Erasmus clinical datasets.
The letter also requested subgroup analyses be conducted in subgroups based on participants’ sex, age, race, and other stratification factors and important disease characteristics. The FDA also requested a safety update on clinical and nonclinical studies.
The FDA is expected to make a decision on the resubmitted application by Jan. 26, 2018.