FDA tells Exelixis supplemental NDA for cabozantinib to be discussed in March

Exelixis (EXEL) announced that the U.S. Food and Drug Administration has notified the company that the supplemental New Drug Application for cabozantinib for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic NET will be discussed at an Oncologic Drugs Advisory Committee meeting in March 2025. The sNDA is based on the final results of the phase 3 CABINET pivotal trial, conducted by the National Cancer Institute’s National Clinical Trials Network, evaluating cabozantinib compared with placebo in advanced pNET and advanced epNET. In August 2024, Exelixis announced that the FDA granted orphan drug designation to cabozantinib for the treatment of pNET and assigned a Prescription Drug User Fee Act target action date of April 3, 2025. As announced in August 2023, the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board unanimously recommended that enrollment in the CABINET trial be stopped and randomized patients be unblinded to therapy with the allowance for crossover from placebo to cabozantinib due to the substantial improvement in progression-free survival observed at this interim analysis. Final results from the enrolled patient population, which were presented at the 2024 European Society of Medical Oncology Congress and published concurrently in the New England Journal of Medicine, confirmed statistically significant and clinically meaningful improvements with cabozantinib versus placebo in the primary endpoint of PFS by blinded independent central review. Additional analyses supported consistency of benefit across all clinical subgroups examined, including primary tumor site, grade and prior systemic anticancer therapy.