Strosberg Discusses Lutathera Approval, Remaining Challenges in NETs

Excerpt:

“Findings from the phase III NETTER-1 trial led to the January 2018 FDA approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic tumors (GEP-NETs). The trial compared Lutathera with high-dose octreotide LAR for patients with 1 or 2 metastatic midgut NETs.

“In NETTER-1, patients with midgut NETs who progressed on 30 mg of octreotide were randomized to Lutathera (n = 116) or high-dose octreotide (n = 113). Patients received 4 doses of Lutathera at 7.4 GBq every 8 weeks in combination with 30 mg of octreotide. The control arm received 60 mg of octreotide LAR every 4 weeks.”

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A New Regulatory Threat to Cancer Patients

Excerpt:

“The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.”

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Cabozantinib Active in Carcinoid Tumors and Pancreatic NETs

Excerpt:

“Cabozantinib (Cabometyx) demonstrated promising clinical activity in patients with carcinoid tumors and pancreatic neuroendocrine tumors (NETs) in a phase II trial.

“Patients with advanced carcinoid tumors (n = 41) or pancreatic NETs (n = 20) were enrolled in parallel cohorts. Both groups received 60 mg of oral cabozantinib daily and were restaged every 2 months for the first 6 months, and then every 3 months.”

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Kulke Sheds Light on Emerging Agents for Neuroendocrine Tumors

Excerpt:

“Several emerging agents are rapidly advancing the treatment paradigm for patients with neuroendocrine tumors (NETs).

“Lutathera (lutetium Lu 177 dotate) was approved by the FDA in January 2018 for patients with somatostatin receptor–positive gastroenteropancreatic NETs. The approval follows the findings of the phase III NETTER-1 trial, which demonstrated a 79% reduction in the risk of progression or death with Lutathera compared with octreotide LAR.”

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FDA Approves New Treatment for Certain Digestive Tract Cancers

Excerpt:

“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). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.”

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Chemotherapy Drug Maintains Quality of Life Despite Side Effects

Excerpt:

“Patients with advanced neuroendocrine tumors (NETs) reported similar health-related quality of life (HRQOL) during treatment with a recently approved chemotherapy drug as compared to patients receiving a placebo treatment, according to a clinical trial published in Lancet Oncology.

“These findings, in conjunction with previous research showing delayed disease progression, suggest the drug, called everolimus, may be able to preserve quality of life even in light of chemotherapy’s often-toxic side effects. The findings support the usefulness of HRQOL as an endpoint in clinical trials studying NETs, in a secondary analysis of their findings, according to the study.”

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Good Outcomes with Cabozantinib in Carcinoid, PNET Tumors

Excerpt:

“Treatment with cabozantinib was tied to objective tumor responses and promising progression-free survival (PFS) in patients with advanced carcinoid and pancreatic neuroendocrine tumors (pNET), researchers reported here.

“With a daily cabozantinib (Cabometyx, Cometriq) treatment, 15% of 20 patients with pNET achieved partial response (95% CI 5-36%) and 75% achieved stable disease (95% CI 53-89%), which was the the trial’s primary endpoint, according to Jennifer Chan, MD, MPH, of the Dana-Farber Cancer Institute in Boston, and colleagues.”

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Challenges in Creating a Multidisciplinary Practice for Patients With NETs

Excerpt:

“Bringing coordinated multidisciplinary cancer treatment together into one place is ideal to improve care for patients with neuroendocrine tumors (NETs), according to David C. Metz, MD, who spoke to the challenge of establishing a multidisciplinary clinical practice for patients with NETs during a presentation at the 10th Annual NANETS Symposium in Philadelphia, Pennsylvania.”

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FDA Accepts Resubmission of Lutathera NDA for GEP-NETs

Excerpt:

“The FDA has accepted a resubmitted new drug application (NDA) for Lutathera (lutetium [177Lu] oxodotreotide) for the treatment of patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision on or before January 26, 2018.

“The NDA is based on the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs. In this trial, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide.”

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