FDA approves Lutathera for digestive tract cancers

Cropped SingleCare logo By | March 28, 2018
Medically reviewed by Karen Berger, Pharm.D.

New Federal Drug Administration (FDA) approvals often mean better and more affordable treatments for people. And that’s the case with the FDA announcement from January 2018, which said it approved Lutathera (lutetium Lu 177 dotatate) for medical use. The decision comes after the FDA examined evidence from two studies presented by pharmaceutical and oncology company Novartis. One of the studies showed that 16% of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who took Lutathera experienced complete or partial tumor shrinkage.

The other study was performed in combination with a drug called Sandostatin (octreotide), which can also be used to treat gastroenteropancreatic tumors (tumors of the digestive tract and pancreas). This study supported the claim that Lutathera could be used to treat GEP-NETs. The studies were analyzed as part of the FDA’s Priority Review program, which is structured to provide funding and quick review to drugs that are designed for the treatment of rare or underfunded diseases.

What is Lutathera?

Lutathera is a drug to treat a type of digestive tract cancer called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). GEP-NETs are diagnosed in one in every 27,000 people per year. While most common in the pancreas, these tumors can appear throughout the digestive tract, including the stomach, intestines, and rectum.

It is important to note that Lutathera does not work with all GEP-NETs. It works against tumors that have a type of receptor that attracts a hormone called somatostatin. The drug itself is a radioactive drug (known as a radiopharmaceutical). It is taken intravenously and travels through the bloodstream until it encounters a tumor cell. It attaches itself to the cell and subjects it to radioactivity, which causes damage to the cell and prevents it from metastasizing (multiplying and spreading).

Common side effects of Lutathera

There may be serious side effects for patients who take Lutathera. Due to the radioactive nature of the drug, it can subject otherwise healthy cells to harmful radiation, causing radiation sickness. Side effects include (but are not limited to) the development of cancers in the bone marrow, low white blood cell count, nausea/vomiting, liver and kidney damage, and interaction with levels of hormones throughout the body, which can lead to low blood sugar or high levels of potassium.

Safety protocols

Lutathera can also cause infertility in both men and women. It can cause harm to a fetus—as such, any women who are pregnant or planning to become pregnant should consult with their doctor before deciding on a course of Lutathera. Due to the nature of radioactive drugs, any person living with a patient taking Lutathera should observe radioactive safety protocols that limit their exposure to the harmful materials. Patients are advised to consult with medical professionals on the best course of action.

Interactions with other drugs

Due to this drug’s ingredients, it can react with other medications, such as lanreotide, octreotide, or pasireotide. Due to possible interactions with these drugs, your doctor will adjust Lutathera treatment if necessary.

Asking your doctor about Lutathera

Lutathera is FDA-approved and available for doctors to prescribe to patients with GEP-NETs. It is most commonly administered every eight weeks, with a total of four injections.