FDA Approves Lutathera for Certain Digestive Tract Cancers

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved Lutathera (lutetium Lu 177 dotatate) to treat people with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). GEP-NETs can occur in the pancreas, stomach, intestines, colon, rectum, or elsewhere in the gastrointestinal tract.

This is the first time a radioactive drug, also called a radiopharmaceutical, has been approved for GEP-NET treatment. It’s for adults with somatostatin receptor-positive GEP-NETs. Somatostatin is a type of hormone. Lutathera works by attaching to the receptor (protein), which is part of the cancer cell, allowing radiation to enter the cell and cause damage.

Approval of a new drug is significant for these types of tumors because they are rare and have limited treatment options. The FDA based its approval on 2 studies.

The first study was a randomized clinical trial of 229 people with a certain type of advanced somatostatin receptor-positive GEP-NET. It measured progression-free survival, which is the length of time the tumors did not grow after treatment. People in the study who received Lutathera and the chemotherapy drug octreotide had longer progression-free survival than those who received octreotide alone.

The second study was based on the data of 360 people with somatostatin receptor-positive GEP-NETs, who all received Lutathera. Complete or partial tumor shrinkage was reported in 16% of the patients.

The FDA approved Lutathera under its priority review program, which is meant to speed up approval of drugs that would significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition. Lutathera was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

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

Serious side effects of Lutathera include low levels of blood cells, development of certain blood or bone marrow cancers, kidney damage, liver damage, abnormal levels of hormones in the body, and infertility. Women who are pregnant or might become pregnant should be advised that Lutathera can cause harm to a developing fetus.

Lutathera is given intravenously and does expose those taking it to radiation. Other patients, medical personnel, and household members should limit their radiation exposure in accordance with radiation safety practices.

Lutathera is marketed by Advanced Accelerator Applications.

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