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# NDA Approved for Radiopharmaceutical to Treat Certain Tumors
- URL: https://www.fdaweb.com/nda-approved-for-radiopharmaceutical-to-treat-certain-tumors/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140608

FDA has approved an Advanced Accelerator Applications NDA for Lutathera (lutetium Lu 177 dotatate) for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency says this is the first radiopharmaceutical approved for treating the tumors. The drug works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

CDER Oncology Center of Excellence director **Richard Pazdur** [says the approval ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm?ref=fdaweb.com)demonstrates how FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment. Approval was based on data from two studies. The first involved 229 patients with a certain type of advanced somatostatin receptor-positive GEP-NET. Patients in the trial either received Lutathera in combination with the drug octreotide or octreotide alone. “Progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone,” FDA says.

The second study involved 1,214 patients with somatostatin receptor-positive tumors, including GEP-NETS, who received Lutathera at a single site in the Netherlands. “Complete or partial tumor shrinkage was reported in 16 percent of a subset of 360 patients with GEP-NETs who were evaluated for response by the FDA,” thr agency says. “Patients initially enrolled in the study received Lutathera as part of an expanded access program.”

Common side effects observed in the studies include low levels of white blood cells, high levels of enzymes in certain organs, vomiting, nausea, high levels of blood sugar, and low levels of potassium in the blood.