New methods approved by FDA for treating digestive tract cancers

The drug Lutathera (lutetium Lu 177 dotatate) was approved by US FDA for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which is a new type of cancer that affects either the pancreas or gastrointestinal tract.

Lutathera (lutetium Lu 177 dotatate) is a radioactive drug or radiopharmaceutical that has been approved by FDA. This is an important breakthrough as it is the first radiopharmaceutical drug that is approved as treatment for GEP-NETs. In adult patients with somatostatin receptor-positive GEP-NETs, Lutathera drug was found to be quite effective in nature.

The treatment options for GEP-NETs were limited as it is a rare group of cancers and conventional therapy was not successful in preventing the cancer from proliferating. With US FDA approving the drug Lutathera, it is a ray of hope for patients with these rare forms of cancer. It also establishes that US FDA is now open to considering data from therapies, which are used in an expanded access program.

GEP-NETs may develop in pancreas and in different parts of gastrointestinal tract, such as stomach, intestines, colon, and rectum. Previous studies have reported that approximately one out of 27,000 people were diagnosed with GEP-NETs each year.

Lutathera is a radioactive drug, which works by binding with somatostatin receptor, which is a component of cell and is present in certain tumors. After binding with the receptor, the drug enters the cell and the resultant radiation damages tumor cells.

The drug Lutathera was approved by two research studies: a randomized clinical trial was conducted on 229 patients with a certain type of advanced GEP-NET, which showed positive response to the receptor somatostatin.

In this clinical trial, patients received a combination of Lutathera and octreotide drug or they received only the drug octreotide. In this research study, researchers measured the period of time for which tumors did not grow after the patients received treatment (progression-free survival).

Patients who were prescribed Lutathera and octreotide had longer progression-free survival period than patients who received only octreotide. Compared to patients who received only octreotide, the risk of tumor growth or patient death was lower for patients who received both Lutathera and octreotide .

The second research study was performed on 1,214 patients in Netherlands. These patients were diagnosed with somatostatin receptor-positive tumors, including GEP-NETS. They were administered Lutathera at a single site.

In 16 percent of a subset of 360 patients with GEP-NETs, the tumors shrunk either completely or partially. The US-FDA authorities evaluated the response of these drugs to GEP-NETs. Patients who were enrolled in this study initially received Lutathera as part of an expanded access program. For patients with serious or immediate life-threatening diseases or conditions, expanded access is the way to gain access to investigational drugs for treatment use.

The drug Lutathera has following side-effects: low levels of white blood cells (lymphopenia), high levels of enzymes in certain organs (increased GGT, AST and/or ALT), vomiting, nausea, high levels of blood sugar (hyperglycemia), and low levels of potassium in blood (hypokalemia).

The drug Lutathera has following serious side-effects: low levels of blood cells (myelosuppression), development of certain blood or bone marrow cancers (secondary myelodysplastic syndrome and leukemia), kidney damage (renal toxicity), liver damage (hepatotoxicity), abnormal levels of hormones in human body (neuroendocrine hormonal crises) and infertility.

The drug Lutathera can harm a developing fetus; therefore, women are advised of the potential risk to fetus before undergoing treatment. To administer the drug lutathera, patients are exposed to radiation.

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