Posted from: Tuesday, March 20, 2018 - 01:50 PM - Present

Lutathera Approved to Treat Neuroendocrine Tumors

January 26, 2018 – The U.S. FDA has approved Lutathera® (lutetium Lu 177 dotatate), manufactured by Advanced Acceleration Applications, a subsidiary of Novartis. The first FDA-approved peptide receptor radionuclide therapy (PRRT), Lutathera is indicated to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

The FDA reports that an estimated 1 in 27,000 Americans are diagnosed with GEP-NETs annually. This rare form of cancer affects the cells of the endocrine and nervous systems of the body. The tumors, which are typically found in the pancreas and other parts of the gastrointestinal tract, can interfere with the body’s ability to properly regulate hormone production. When initial treatment fails to prevent the spread of GEP-NETs, treatment options are limited. Prognosis is typically poor.

Lutathera works by binding to somatostatin receptors found on cancerous cells. The drug then enters the tumor cells, damaging them via radiation. In one clinical trial, Lutathera reduced the risk of disease progression or death by 79%. Another study, conducted in the Netherlands, found that 16% of patients treated with Lutathera experienced complete or partial tumor shrinkage.

As a radiopharmaceutical, Lutathera can only be administered by or under the direction of physicians trained, experienced, and licensed in the safe use and handling of such drugs to minimize radiation exposure. Initial recommended dosing is two vials administered via intravenous infusion every eight weeks for a total of four doses.

The product has already been launched, at a wholesale acquisition cost (WAC) of $47,500 per dose.


Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Sunday, October 20, 2019 - 09:04 AM.