The drug Lutathera (lutetium Lu 177 dotatate) was approved by US FDA for treating neuroendocrine tumors that originate in the gastrointestinal tract and pancreas (GEP-NETs). This is an important breakthrough as it is the first radioactive drug to have been approved by the FDA. It is now a novel treatment for GEP-NETs.
Lutathera drug was found to be quite effective in treating adult patients with GEP-NETs. The treatment options for GEP-NETs were limited as it is a rare type of cancer and the conventional therapy was not successful in preventing the proliferation of this cancer. With US FDA approving the drug Lutathera, it is a ray of hope for patients diagnosed with these rare type of cancer.
It also establishes that US FDA is now open to considering data from alternative therapies, which can provide hope to patients with this rare type of cancer. GEP-NETs develop not only in the pancreas but also in different parts of the digestive system, such as stomach, colon, intestine, and rectum.
Statistical data suggests that the diagnosis of GEP-NETs has been low each year. Only one out of 27,000 people develop this cancer in the United States of America. Lutathera is a radiopharmaceutical drug. It exerts its therapeutic activity by clinging to the somatostatin receptor, which is a component of cell and is present in certain types of tumors.
After clinging to the receptor, the drug gets into the cell and exudes radiation to damage cancerous activity. The drug Lutathera was approved by two research studies: a randomized clinical trial was conducted on 229 patients, who were diagnosed with a certain type of advanced GEP-NET. These patients elicited a positive response to the drug.
In this clinical trial, a combination of Lutathera and octreotide drug was administered to some patients, while the remaining patients only received octreotide drug. After providing treatment to patients, researchers measured the period of time for which tumors did not show any signs of grow or development. This period was defined as progression-free survival of patients.
Patients who consumed a combination of Lutathera and octreotide drugs had a longer period of progression-free survival as compared to patients who only consumed the drug octreotide. Moreover, the possibility of the growth of tumors or death was lower in patients who received both the drugs: Lutathera and octreotide .
The second research study was performed on 1,214 patients in Netherlands. These patients were diagnosed with tumors showing positive response to somatostatins, including GEP-NETS. The drug Lutathera was administered at a single site in these patients.
In a clinical trial that included 360 patients with GEP-NETs, it was found that tumors either shrunk completely or partially in about 16 percent of included patients . These patients also received the drug Lutathera initially, and their responses were monitored by the US FDA.
The drug Lutathera has following side-effects: the white blood cells decrease sharply in patients (lymphopenia); the levels of enzymes become high in certain organs (increased GGT, AST and/or ALT); some patients may develop nausea and vomiting; there could be a sudden spike in blood sugar levels (hyperglycemia), and the levels of potassium become low in the blood (hypokalemia).
The drug Lutathera has following serious side-effects: blood cells may decrease sharply in numbers (myelosuppression); certain types of blood or bone marrow cancers may develop in patients(secondary myelodysplastic syndrome and leukemia); some patients may witness a serious damage to their kidneys (renal toxicity); some patients may suffer from permanent liver damage (hepatotoxicity); the hormonal levels may become abnormal in the human body (neuroendocrine hormonal crises), and infertility.
The drug Lutathera can harm the fetus developing in the womb of a pregnant mother; therefore, pregnant women are educated about the potential damage caused to the fetus by this drug . In general, radiation exposure is provided to patients before administering the drug.