TAMPA, Fla. – The Food and Drug Administration announced on Friday the approval of Lutathera® (177Lu-Dotatate) to treat patients with gastroenteropancreatic neuroendocrine tumors. Lutathera is a novel treatment known as peptide receptor radionuclide therapy, which is delivered intravenously. When injected in a patient, the radiopharmaceutical treatment binds to neuroendocrine tumor cells, delivering a high dose of targeted radiation to the cancer. This is a first-of-its-kind cancer treatment and is intended for patients who have progressed on somatostatin analogs.

Moffitt Cancer Center’s Jonathan R. Strosberg, M.D., head of the Neuroendocrine Tumor Program, served as a lead investigator of NETTER-1, an international clinical trial spanning 41 centers that tested the new therapy manufactured by Advanced Accelerator Applications.

“Patients with neuroendocrine tumors often have advanced disease that has spread to other parts of the body. To date, treatment options for these cancer patients have been very limited. Lutathera is an effective option to delay tumor progression for patients who before today had few options available,” said Strosberg.

In 2017, The New England Journal of Medicine reported on the results of the NETTER-1 trial, highlighting key findings:

“…. treatment with 177Lu-Dotatate resulted in a risk of progression or death that was 79% lower than the risk associated with high-dose octreotide LAR. The estimated rate of progression-free survival at month 20 was 65.2% (95% CI, 50.0 to 76.8) in the 177Lu-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The median progression-free survival was 8.4 months in the control group and had not yet been reached in the 177Lu-Dotatate group.” 

“Before Lutathera, we typically saw response rates average around 5 percent in large clinical trials,” added Strosberg. “Now, we are seeing objective radiographic response rates of nearly 20 percent and stable disease in the majority of cases.  As a clinician who treats more than 500 patients a year with this disease, having this new therapy available is very encouraging.”

Following FDA approval, Lutathera will be offered commercially to U.S. and international patients. Moffitt Cancer Center will be one of the U.S. cancer centers offering treatment.

Media Availability: Strosberg is available for interview; please contact Kim Polacek, 813-745-7408//Kim.Polacek@Moffitt.org

Advanced Accelerator Applications News Release: https://www.novartis.com/news/media-releases/advanced-accelerator-applications-receives-fda-approval-lutatherar-treatment-gastroenteropancreatic-neuroendocrine-tumors

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