Exelixis Gets Expanded FDA Approval of Cabometyx in Advanced Neuroendocrine Tumors

 Exelixis has won U.S. Food and Drug Administration expanded approval of its Cabometyx cancer drug for certain patients with advanced neuroendocrine tumors.

Exelixis on Wednesday said the approval covers Cabometyx for patients 12 and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors.

The Alameda, Calif., oncology company said the green light makes Cabometyx the first and only systemic treatment that is FDA-approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression and functional status.

Neuroendocrine tumors are heterogeneous tumors that arise from the neuroendocrine cells of the digestive tract and other organs, such as the lung and pancreas, and most patients with advanced disease face a poor prognosis, Exelixis said.

The company's cabozantinib franchise, anchored by Cabometyx, generated $1.81 billion in U.S. net product revenue last year.

https://www.morningstar.com/news/dow-jones/202503266285/exelixis-gets-expanded-fda-approval-of-cabometyx-in-advanced-neuroendocrine-tumors