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# FDA accepts Cabometyx sNDA for Pancreatic Tumors
- URL: https://www.fdaweb.com/fda-accepts-cabometyx-snda-for-pancreatic-tumors/
- Published: 2024-08-06T12:00:00.000Z
- Updated: 2026-09-14T14:37:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157512

FDA has accepted for review an Exelixis supplemental NDA for Cabometyx (cabozantinib) and its use for treating adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic and extra-pancreatic neuroendocrine tumors. The agency assigned a standard review with a user fee review action target date of 4/3/2025.

The sNDA is based on data from the Phase 3 CABINET pivotal trial evaluating cabozantinib compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET, according to the company. “As previously [announced](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fir.exelixis.com%2Fnews-releases%2Fnews-release-details%2Fexelixis-announces-positive-results-phase-3-cabinet-pivotal&esheet=54104895&newsitemid=20240805262570&lan=en-US&anchor=announced&index=2&md5=53223185091879989b2b561c3bb53687&ref=fdaweb.com), CABINET was stopped early for compelling activity; all patients were unblinded and those on placebo were given the option to cross over to active treatment with cabozantinib,” it says, adding that the move was due to a “dramatic improvement in progression-free survival” seen during an interim analysis.

Cabometyx is currently approved as monotherapy for treating patients with advanced renal cell carcinoma (RCC) and in combination with nivolumab as a first-line treatment for patients with advanced RCC. It is also approved for treating patients with hepatocellular carcinoma who have been previously treated with sorafenib; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer.