FDA Approves Digestive Cancer Drug

The FDA recently approved lutetium Lu 177 dotate (Luthathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which is a type of cancer that affects the pancreas or the gastrointestinal tract.

Lutetium Lu 177 dotate is indicated for adults with somatostatin receptor-positive GEP NETs, according to a press release.

The FDA reported that this is the first time a radiopharmaceutical has gained FDA approval for the treatment of GEP-NETs.

“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 the FDA Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research. “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.”

GEP-NETs can develop in the pancreas and various parts of the gastrointestinal tract, including the stomach, intestines, colon, and rectum. This type of cancer affects 1 out of 27,000 patients per year, according to the FDA.

Lutetium Lu 177 dotate is a radioactive drug that binds to the somatostatin receptor. After binding, the drug penetrates the cancer cell and causes radiation damage that results in cell death, according to the release.

The new approval was supported by 2 studies, according to the FDA.

The first clinical trial included 229 patients with advanced somatostatin receptor-positive GEP-NET who were randomized to receive lutetium Lu 177 dotate plus octreotide or octreotide monotherapy.

The researchers found that progression-free survival (PFS) was longer for patients treated with the lutetium Lu 177 dotate combination compared with octreotide monotherapy, which met the trial’s endpoint of PFS, according to the study.

Included in the second trial were 1214 patients with somatostatin receptor-positive tumors who were treated with lutetium Lu 177 dotate.

The researchers found that 16% of a subset of 360 patients with GEP-NETs achieved a complete or partial tumor shrinkage, according to the release.

The FDA reports that common adverse events of lutetium Lu 177 dotate include lymphopenia, increased GGT, AST, and/or ALT, vomiting, nausea, hyperglycemia, or hypokalemia.

Lutetium Lu 177 dotate was approved under the priority review pathway and was also granted FDA orphan drug designation, according to the release.