FDA Greenlights Cabozantinib for Treated Advanced Neuroendocrine Tumors

The U.S. Food and Drug Administration (FDA) has recently given the green light to cabozantinib, marketed under the name Cabometyx, for patients with advanced neuroendocrine tumors who have previously undergone treatment. This approval sets a new benchmark in the treatment of these complex conditions, as per an announcement from the Dana-Farber Cancer Institute.

The endorsement of cabozantinib is grounded in the outcomes of the phase 3 CABINET study. This research compared the efficacy of cabozantinib against a placebo in individuals suffering from advanced pancreatic neuroendocrine tumors and advanced extrapancreatic neuroendocrine tumors, all of whom had received prior treatments. The findings, which were made public in the New England Journal of Medicine last September, demonstrated that patients receiving cabozantinib had a significantly longer survival period without disease progression compared to those on placebo. As a result of these promising outcomes, the study was concluded ahead of schedule and unblinded in August 2023.

The profile of side effects for cabozantinib, as noted in the study, aligns with those observed in previous research, including conditions such as hypertension, fatigue, and diarrhea. Despite these side effects, the treatment offers a significant advancement for patients grappling with neuroendocrine tumors. Dr. Jennifer Chan, the principal investigator of the CABINET study from the Dana-Farber Cancer Institute, highlighted the arduous journey faced by patients with neuroendocrine tumors. She pointed out that although there have been advancements in treatment options, a substantial need remained for effective therapies for patients whose cancer had progressed or metastasized. Cabozantinib's ability to markedly improve outcomes for this patient group brings a renewed sense of hope with the FDA's approval.

This development is a significant milestone, with the approval being awarded to Exelixis, the biotechnology company behind cabozantinib. The decision is expected to positively impact many patients by offering an effective new treatment avenue, potentially improving quality of life and extending survival rates for those affected by these aggressive tumors. As a result, cabozantinib now stands as a vital option in the therapeutic landscape for neuroendocrine tumors, marking a pivotal progression in cancer treatment options.