Exelixis Advances CABOMETYX for Neuroendocrine Tumors Ahead of FDA Review in 2025

Exelixis Advances in Neuroendocrine Tumor Treatment with Cabozantinib

Exelixis, Inc. is poised for a significant milestone as it prepares for an upcoming discussion with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for cabozantinib, marketed as CABOMETYX®. The FDA's Oncologic Drugs Advisory Committee (ODAC) is scheduled to review the application in March 2025. This sNDA focuses on the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET). The application is supported by the final results of the phase 3 CABINET pivotal trial, conducted under the auspices of the National Cancer Institute's National Clinical Trials Network. This development underscores Exelixis' commitment to addressing unmet medical needs in the oncology space.

The CABINET trial, a multicenter, randomized, double-blinded, placebo-controlled study, evaluates the efficacy of cabozantinib in patients with advanced neuroendocrine tumors who have undergone previous therapy. The trial garnered attention earlier in August 2023 when the independent Data and Safety Monitoring Board recommended halting patient enrollment due to significant improvements in progression-free survival (PFS). This recommendation led to the unblinding of patients, allowing those on placebo to switch to cabozantinib, highlighting the drug's promise in improving patient outcomes. The final results, which revealed substantial enhancements in PFS across various clinical subgroups, were subsequently shared at the 2024 European Society of Medical Oncology Congress and published in the New England Journal of Medicine.

In addition to the upcoming ODAC meeting, cabozantinib has already received orphan drug designation from the FDA for pNET, a testament to its potential in treating rare conditions. The Prescription Drug User Fee Act (PDUFA) target action date for the sNDA is set for April 3, 2025. Exelixis’ collaboration with the National Cancer Institute on the CABINET trial emphasizes its commitment to advancing cancer research and developing innovative treatments that can significantly impact patient care. As discussions with the FDA approach, the company stands at the forefront of potentially transformative therapies in the oncology sector.

Exelixis continues to strengthen its position in the oncology market with its focus on neuroendocrine tumors. The commitment to research and development, coupled with strategic collaborations, positions the company well for future growth as it seeks to expand the therapeutic landscape for patients enduring these challenging cancers.