FDA Approves New Treatment for Some Digestive System Cancers

This page was originally published January 27, 2018 and updated June 1, 2024.

On Friday, January 26, 2018, The US Food and Drug Administration (FDA) announced its approval of Lutathera for certain gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a type of cancer that affects the pancreas or gastrointestinal tract. GEP-NETs are uncommon, affecting about 1 in 27,000 people each year. Historically, it’s been a challenge to find effective treatment options for this type of cancer.

Lutathera works by binding to receptors on certain tumors.  This is the first time a radiopharmaceutical, or radioactive drug, has obtained approval for treatment of GEP-NETs. Director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research Richard Pazdur, M.D. said, “GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing…This approval provides another treatment choice for patients with these rare cancers.”

Two studies supported this expanded use of Lutathera – one involving 229 patients and the other with a larger population of 1,214 patients. In the smaller study, patients were either given Lutathera and octreotide or just octreotide alone. Patients who received both had progression-free survival rates much longer than those that received octreotide by itself. The findings suggested that the risk of tumor growth and patient death was lower in those patients who received Lutathera and octreotide in combination. In the larger study conducted in the Netherlands, a subset of 360 patients was examined for tumor growth. In 16% of this patient subset, partial or complete tumor shrinkage was reported after taking a course of Lutathera.

Some of the reported side effects from taking Lutathera are 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.

More serious issues 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.

More information on this drug, its indications, risks and benefits, visit the Novartis website. Be sure to check with your doctor regarding your care plan to see if this treatment is an option for you; he or she is your best source of information.

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