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177Lu-DFC413 is an investigational lutetium-177–labeled radioligand therapy being developed by Novartis for the treatment of advanced solid tumors, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, hormone receptor–positive/HER2-negative and triple-negative breast cancer, colorectal cancer, and soft tissue sarcoma.[1][3][6] It is administered after patient selection with the companion PET imaging agent 68Ga-NNS309, which identifies tumors expressing the target of DFC413, enabling a theranostic approach.[1][3] Once bound to its tumor-associated target, the 177Lu beta emissions deliver localized radiation to malignant cells and nearby tissue, producing cytotoxic DNA damage while permitting dosimetry, pharmacokinetic, and safety characterization in a first-in-human phase I trial.[1][3]
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