New Drug in Development Shows Improved Progression-Free Survival for Patients with Advanced Metastatic Midgut Neuroendocrine Tumors

Excerpt:

“A new therapy in development for the treatment of midgut neuroendocrine tumors, a rare type of cancer that occurs in the small intestine and colon, shows improved progression-free survival and response rates for patients with advanced disease. Results of the international phase 3 clinical trial of lutetium-177 (177Lu)-Dotatate compared to high-dose octreotide LAR were published in the Jan. 12 issue of the New England Journal of Medicine.

” ‘Patients diagnosed with midgut neuroendocrine tumors often have advanced disease that has spread to other sites. Treatment options are limited. 177Lu-Dotatate is an effective option to delay tumor progression for patients with this disease,’ says Jonathan R. Strosberg, head of the Neuroendocrine Tumor Program at Moffitt Cancer Center. ‘There is also preliminary evidence of survival benefit that requires confirmation on final survival analysis, expected in several years.’ ”

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FDA Issues Complete Response Letter for Lutathera in Neuroendocrine Tumors

Excerpt:

“The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.

“The CRL, which follows a discipline review letter (DRL) issued in November, requests new subgroup data, a safety update, and that revisions be made to the previously submitted data. The letter did not request the initiation of additional studies of Lutathera.”

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How to Find Clinical Trials for Experimental Cancer Treatments

Excerpt:

“Who might benefit from a clinical trial for an experimental cancer treatment?

“A common misperception is that such trials are strictly for patients who have reached the end of the road and have no more hope of being helped by standard treatments.

” ‘But it’s not last-ditch,’ said Dina G. Lansey, the assistant director for diversity and inclusion in clinical research at the Johns Hopkins Kimmel Cancer Center. New forms of immunotherapy are being tested in many types of cancer, and not just at late stages.”

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Advanced Accelerator Applications Reports 15.4% Sales Growth in the Third Quarter of 2016 and Feedback from the FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors

Excerpt:

“Advanced Accelerator Applications S.A. …an international specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.”

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Long-Term Experience Supports Efficacy and Safety of PRRT for Treating Neuroendocrine Tumors

Excerpt:

“More than ten years of published clinical data and personal experience using PRRT-based targeted therapy of neuroendocrine tumors supports the effectiveness of this novel treatment approach and the ability to minimize and manage potential toxic side effects. A comprehensive review of somatostatin analog peptide receptor radionuclide therapy (PRRT) is published in Cancer Biotherapy and Radiopharmaceuticals.”

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SPINET Trial Could Alter Practice for Patients With Lung NETs

Excerpt:

“Since its FDA approval in 2014, the somatostatin analog lanreotide (Somatuline Depot) has been creating fresh options for select patients with gastroenteropancreatic neuroendocrine tumors (NETs), given the significant improvement in progression-free survival (PFS) demonstrated in this population.

“Now, investigators are examining the potential that the agent could have in patients with lung NETs—an area that is greatly lacking in research— in a potentially practice-changing clinical trial that seeks to determine the role of the synthetic growth inhibitory hormone in patients with the rare tumor type. Thus far, no prospective trials specifically for patients with lung NETs have been reported, researchers have noted.”

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NET Oncogene Patterns Don’t Fit the Classic Mold

Excerpt:

“Matthew H. Kulke, MD, MMSc, has been a leader in the development of new therapies and clinical management strategies for patients with neuroendocrine tumors (NETs).

“In a recent milestone, Kulke presented phase III clinical trial data at the 2015 European Cancer Congress indicating that telotristat etiprate, a novel tryptophan hydroxylase inhibitor, improves diarrhea control in combination with a somatostatin analog for patients with metastatic NETs and inadequately controlled carcinoid syndrome. In the clinical arena, Kulke serves as co-chair for the National Comprehensive Cancer Network guidelines panel on NETs and also is an active member of medical society advisory boards and task forces related to NETs.”

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Excitement Continues to Build for Advances in Neuroendocrine Tumor Field

Excerpt:

“It’s been an exciting year thus far for patients with neuroendocrine tumors (NETs), with the FDA approving a new treatment regimen and more advancements on the horizon, according to James C. Yao, MD, a professor in the Department of Gastrointestinal (GI) Medical Oncology at The University of Texas MD Anderson Cancer Center.

“In February, the FDA approved everolimus (Afinitor) as a treatment for patients with progressive, well-differentiated, non-functional NETs of GI or lung origin with unresectable, locally advanced or metastatic disease. The mTOR inhibitor has been approved since 2011 for unresectable or advanced pancreatic NETs.

“Meanwhile, the agency is evaluating Lutathera (177Lutetium DOTA-octreotate), a peptide receptor radionuclide therapy (PRRT), for patients with gastroenteropancreatic NETs under its priority review program. Similarly, telotristat etiprate, a small-molecule tryptophan hydroxylase inhibitor, also is being considered under the FDA’s priority review program for carcinoid syndrome in patients with metastatic NETs.”

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Advanced Accelerator Applications Announces FDA Priority Review for Lutathera

Excerpt:

“Advanced Accelerator Applications S.A…, an international specialist in Molecular Nuclear Medicine (MNM), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The Prescription Drug User Fee Act (PDUFA) target action date is December 28, 2016.

“Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.”

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