Is lutetium Lu 177 dotatate an orphan drug?
FDA granted priority review for this application and previously granted Orphan Drug designation to lutetium Lu 177 dotatate for treatment of GEP-NETs.
How often do you give lutetium Lu 177?
Lutetium Lu 177 dotatate (7.4 GBq [200 mCi]) was administered every 6 to 13 weeks for up to 4 doses. The ORR was 16% (n=58), including 3 complete responses in this subset of 360 patients with GEP-NETs who were assessed according to RECIST criteria.
What is lutetium Lu 177-dotatate used for?
FDA label information for this drug is available at DailyMed. Lutetium Lu 177-dotatate is approved to treat: Gastroenteropancreatic neuroendocrine tumors. It is used in adults whose cancer is somatostatin receptor positive. Lutetium Lu 177-dotatate is also being studied in the treatment of other types of cancer.
How effective is Lu-dotatate for cancer treatment?
Overall, 18% of patients in the 177 Lu-Dotatate group experienced significant tumor shrinkage, compared with only 3% in the octreotide LAR group. Historically, tumor responses in these patients are uncommon. So the double-digit tumor response rates seen in this trial "are very high," he said.
How much does Lutathera treatment cost?
Advanced Accelerator said Lutathera's list price is about $47,500 per dose, with the usual treatment period including four doses.
Who can administer Lutathera?
The radiopharmaceutical infusion will usually be administered by a nuclear medicine technologist or nuclear medicine physician, depending upon the institution. These individuals are sometimes called the “authorized user.” The LUTATHERA infusion should be conducted over the course of 30 to 40 minutes.
What is lutetium Dotatate therapy?
Lutetium Lu 177 dotatate, a peptide receptor radionuclide therapy (PRRT), is a tumor-targeted treatment that uses radiation to induce tumor cell death in neuroendocrine tumors (NETs) via a β particle-emitting radionuclide linked to a somatostatin peptide analog.
Can Lutathera shrink tumors?
Lutathera treatment helps make the tumors grow more slowly, shrink, or stop them from growing altogether, and can also help manage the symptoms caused by the tumors.
How many times can you have PRRT?
You usually have PRRT every 2 to 3 months. You have up to 4 doses of treatment.
What types of cancers are Lutathera used for?
The U.S. Food and Drug Administration today 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).
When will the FDA approve lutetium 177?
On March 23, 2022, the FDA approved Pluvicto (active ingredient lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based ...
How is lutetium administered?
Infuse lutetium Lu 177 dotatate via IV at a rate of 50–100 ml per hour for 5–10 minutes, then 200–300 ml per hour for an additional 25–30 minutes. Do not administer it as an IV bolus. Administer long-acting octreotide 30 mg intramuscularly 4–24 hours after each lutetium Lu 177 dotatate dose.
Is lutetium approved?
Lutetium-PSMA-617 (Lu-PSMA) is now FDA-approved for patients with metastatic castration-resistant prostate cancer who have received certain other treatments (androgen receptor pathway targeting agents and taxane-based chemotherapy). Patients must also have a positive PSMA PET scan.
Does Lutathera cause hair loss?
hair loss, high blood pressure (hypertension), cough, and. constipation.
Can neuroendocrine tumors shrink on their own?
Most neuroendocrine tumors grow slowly -- over years, not months -- compared with other types of tumors. Often, doctors can remove or shrink them with different treatments. Other therapies can make your symptoms better.
How long does Lutathera stay in your system?
The radiation in LUTATHERA® will be detectable in your urine for up to 30 days. You should stay well hydrated before, during, and after your treatment and urinate frequently.
How much Lu 177 dotatate should I take?
The recommended dose of lutetium Lu 177 dotatate is 7.4 GBq (200 mCi) as an intravenous infusion over 30 minutes every 8 weeks for a total of 4 doses.
How often is Lu 177 administered?
Lutetium Lu 177 dotatate (7.4 GBq [200 mCi]) was administered every 6 to 13 weeks for up to 4 doses.
What is Lu-Dotatate used for?
177 Lu-Dotatate is different from other somatostatin analogues used to treat NETs in an important way: it incorporates a radioactive isotope. The somatostatin analogue component of the drug is octreotate, which has a stronger affinity than other somatostatin analogues for a key receptor on NET cells, Dr. Strosberg said.
Is Lu dotatate cytotoxic?
Strosberg explained, the drug has a much more substantial cell-killing, or cytotoxic, effect than traditional somatostatin analogues.
Is octreotide LAR a standard of care?
High-dose octreotide LAR is not considered to be a standard of care in this patient population, Dr. Strosberg noted. But because it’s often used in the clinic in this fashion, the trial investigators and regulatory authorities felt that it was a “reasonable choice” for use in the control group, he explained.
