One indication is for treating adults with priorly treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumours (pNET).
Other one is for use in adults with formerly treated, locally advanced/unresectable or metastatic, well- or moderately differentiated extra-pancreatic NET (epNET).
The US regulator assigned a standard review with regulatory decision on the approval under the Prescription Drug User Fee Act expected on 3 April 2025.
Previously, cabozantinib was granted orphan drug designation for the treatment of pancreatic NET (pNET).
The sNDA submission is based on the final results of the Phase III CABINET pivotal trial.
This study evaluated cabozantinib compared to placebo in two cohorts of patients with previously treated advanced pNET and advanced extra-pancreatic NET (epNET).
The trial was stopped early due to a dramatic improvement in progression-free survival (PFS) observed at an interim analysis in both cohorts.
Patients in the CABINET trial who were initially receiving placebo were unblinded and given the option to cross over to active treatment with cabozantinib.
This decision was made following the observation of a statistically significant and clinically meaningful improvement in PFS with cabozantinib versus placebo.
The results were consistent across both local review and available independent blinded central radiology review.
Exelixis Product Development & Medical Affairs executive vice-president and chief medical officer Amy Peterson said: “The FDA’s acceptance of this application marks another important milestone in our commitment to bringing cabozantinib to patients living with difficult-to-treat cancers and who have limited treatment options.
“We appreciate the opportunity to work with the FDA in the coming months as they review our application, with the goal to bring this new, effective treatment option to patients with advanced neuroendocrine tumours as quickly as possible.”