Posted by Michael Wonder on 26 Jan 2018
FDA approves new treatment for certain digestive tract cancers
26 January 2018 - The U.S. FDA today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
This is the first time a radio-active drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.
The approval of Lutathera was supported by two studies. The first was a randomised clinical trial in 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. The study measured the length of time the tumours did not grow after treatment (progression-free survival). Progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone. This means the risk of tumour growth or patient death was lower for patients who received Lutathera with octreotide compared to that of patients who received only octreotide.
