The US Food and Drug Administration (FDA) has approved the radiopharmaceutical Lutathera (lutetium Lu 177 dotatate) as a treatment for certain cancers of the pancreas and gastrointestinal tract. The drug, developed by pharmaceutical group Advanced Accelerator Applications, is the first radioactive drug to gain FDA approval for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Neuroendocrine tumors (NETs) may occur wherever hormone-producing cells are present, but around seven out of ten cases are gastroenteropancreatic (GEP) and are usually found in the small bowel, stomach or rectum.
Lutathera belongs to a class of targeted treatments called Peptide Receptor Radionuclide Therapies. It works by binding to the somatostatin receptors of the cancer cells, enabling the drug to enter the cells of the tumor and cause damage through radiation.
Approval of the drug is particularly significant because limited treatment options for GEP-NETs are available. Existing treatment of GEP-NETs may involve chemotherapy, surgery, and medication, notably somatostatin and analogs, (such as Sandostatin Lar Depot) which are often used to control symptoms.
Lutathera was granted Priority Review and Orphan Drug designation by the FDA. The agency aims to action applications for treatment designated Priority Review within six months because these drugs (if approved) could significantly improve the safety or effectiveness of treatment, diagnosis, or prevention of a serious condition.
“This approval provides another treatment choice for patients with these rare cancers. It also demonstrates how the FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment,” commented Richard Pazdur, MD, 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.
Lutathera’s approval was granted following two studies; one a randomized clinical trial of 229 patients with a certain form of advanced somatostatin receptor-positive GEP-NET, the other based on data from 1,214 patients GEP-NETS and other somatostatin receptor positive tumors.
Common Side Effects of Lutathera:
· Lymphopenia (low white blood cell levels)
· Hyperglycemia (high blood sugar levels)
· High levels of enzymes in certain organs
· Nausea or vomiting
· Hypokalemia (low potassium levels)
Severe Side Effects:
· Low levels of blood cells
· Development of certain bone marrow or blood cancers
· Kidney damage
· Liver damage
· Abnormal levels of hormones
For more information on Lutathera, its uses and side effects, visit http://www.adacap.com/research-development/pipeline/
