FDA Approves First Radioactive Drug for Type of Pancreatic Cancer

01/26/18

The US Food and Drug Administration (FDA) has approved the first radioactive drug for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Lutetium Lu 177 dotatate (Lutathera, Novartis) is indicated for adult patients with somatostatin receptor-positive GEP-NETs. Included in the GEP-NETs subtype are foregut, midgut, and hindgut neuroendocrine tumors.

Lutetium Lu 177 dotate previously received orphan drug designation from the FDA and is the first available FDA-approved peptide receptor radionuclide therapy (PRRT) – a form of targeted treatment comprising a targeted molecule that carries a radioactive component.

The approval came following results of a randomized phase III study, in which lutetium Lu 177 dotate plus the standard of care (octreotide LAR) helped reduce the risk of disease progression or death by 79% compared to standard of care alone. Median progression-free survival was not reached in the lutetium Lu 177 dotate arm, compared with 8.5 months in the standard of care arm.

“The approval of Lutathera marks an important achievement and innovation for the NET community,” said Susanne Schaffert, PhD, Chairperson and President, Advanced Accelerator Applications, a Novartis company, in a press release (January 26, 2018). “As the first PRRT ever approved in the US, Lutathera is introducing a major advancement in the treatment paradigm for these patients that we hope will improve many lives. We believe nuclear medicine has the potential to offer many benefits to cancer patients and will use this approval as a foundation for the development of additional targeted cancer treatments utilizing radiolabeled ligands.”

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Common side effects associated with lutetium Lu 177 dotate include lymphopenia, increased gamma-glutamyl transferase, vomiting, nausea, hyperglycemia, and hypokalemia.—Zachary Bessette