Radioactive drug for digestive cancer snags FDA approval

January 30, 2018

FDA approved a new drug to treat a type of cancer that affects the pancreas or gastrointestinal tract.

A new drug to treat a type of cancer that affects the pancreas or gastrointestinal tract obtained approval from FDA.

Lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) snagged FDA priority review to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

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This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs, according to FDA. 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 tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.

“GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing,” said Richard Pazdur, MD, director of 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, in a statement from FDA.

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“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,” Pazdur added.

Approximately 1 out of 27,000 people are diagnosed with GEP-NETs per year, according to FDA. In fact, according to Reuters, this is the same disease that killed Apple's co-founder Steve Jobs in 2011. 

The approval of Lutathera was supported by two studies, including one that demonstrated that progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone.

The second study was based on data from 1,214 patients with somatostatin receptor-positive tumors, including GEP-NETS, who received Lutathera. Complete or partial tumor shrinkage was reported in 16% of a subset of 360 patients with GEP-NETs.

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