United States: United States FDA Approves New Treatment For Certain Digestive Tract Cancers

On January 26, 2018, the United States Food and Drug Administration (USFDA) approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs)60. This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs including foregut, midgut, and hindgut neuroendocrine tumors.

GEP-NETs are a rare group of cancers with limited treatment options if initial therapy fails to keep the cancer from growing; this approval provides another treatment choice for patients with these rare cancers.

Lutathera was granted Priority Review and received Orphan Drug designation earlier; a designation which provides incentives to assist and encourage the development of drugs for rare diseases. The approval of Lutathera was supported by two studies -

  • The first was a randomized, pivotal phase III clinical trial in 229 patients with a certain type of advanced somatostatin receptor-positive GEP-NET. Patients in the trial either received Lutathera with octreotide or octreotide alone. Progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone. This means the risk of tumor growth or patient death was lower for patients who received Lutathera with octreotide compared to that of patients who received only octreotide.
  • The second study was based on data from 1,214 patients with somatostatin receptor-positive tumors, including GEP-NETS, who received Lutathera at a single site in the Netherlands. Complete or partial tumor shrinkage was reported in 16 percent of a subset of 360 patients with GEP-NETs who were evaluated for response by the FDA. Patients initially enrolled in the study received Lutathera as part of an expanded access program. Expanded access is a way for patients with serious or immediately life- threatening diseases or conditions who lack therapeutic alternatives to gain access to investigational drugs for treatment use.

The FDA had granted the approval of Lutathera to Advanced Accelerator Applications, earlier in October 2017; the Applications being acquired by the global pharmaceutical giant Novartis61.

About GEP-NETs

GEP-NETs, rare tumors originating in the neuroendocrine cells of numerous organs, can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately one out of 27,000 people are diagnosed with GEP-NETs per year. Some patients develop symptoms arising from the excessive production of hormones by neuroendocrine tumor cells, while others remain clinically silent for years. The estimated incidence, or rate of new cases, of NETs in the United States is approximately 6.98/100,000 per year, while the estimated prevalence for 2014, based on the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database, was 171,321.

About Lutathera

Lutathera is a first-in-class drug and the first available FDA-approved Peptide Receptor Radionuclide Therapy (PRRT), a form of treatment comprising a targeting molecule that carries a radioactive component. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells. Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors62. Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel. The patient cannot leave the controlled areas until told to do so by the doctor. Before starting treatment, the doctor will have checked that the patient's tumours have somatostatin receptors on their cell surfaces. Lutathera is given by infusion (drip) into a vein. The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient experiences severe side effects. The patient should also be given an infusion of an amino acid solution which helps protect their kidneys.

Footnotes

60. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm594043.htm

61. https://www.novartis.com/news/media-releases/novartis-announces-planned-acquisition-advanced-accelerator-applications

62. https://www.novartis.com/news/media-releases/advanced-accelerator-applications-receives-fda-approval-lutatherar-treatment-gastroenteropancreatic-neuroendocrine-tumors

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