ODAC to Discuss Exelixis' Application for Cabometyx Label Expansion

Core Viewpoint - Exelixis, Inc. is seeking approval for cabozantinib to treat advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic NET, with a discussion scheduled at an ODAC meeting in March 2025 [1][3]. Company Developments - Exelixis' shares have increased by 48.9% year to date, contrasting with a 7.8% decline in the industry [2]. - The FDA has notified Exelixis about the upcoming ODAC meeting, which will evaluate the safety and effectiveness of cabozantinib for the new indications [3]. - Cabozantinib, marketed as Cabometyx, is currently approved for advanced renal cell carcinoma and other cancers, including hepatocellular carcinoma and differentiated thyroid cancer [4][5]. Clinical Trial Insights - The sNDA for cabozantinib is based on the final results of the phase III CABINET trial, which showed significant improvements in progression-free survival compared to placebo [6][8]. - The trial was halted early due to substantial benefits observed, leading to a recommendation for crossover from placebo to cabozantinib [7]. Future Prospects - Exelixis plans to submit an additional sNDA for cabozantinib in combination with Tecentriq for metastatic castration-resistant prostate cancer later this year [9]. - The company generated $1.3 billion in product revenues in the first nine months of 2024, primarily from Cabometyx sales [9]. - The potential label expansion is expected to further boost sales and diversify Exelixis' oncology portfolio [10]. Pipeline Developments - Zanzalintinib, a next-generation oral TKI, is being evaluated in the late-stage STELLAR-303 study for metastatic colorectal cancer, with preliminary results expected in 2025 [11]. - Exelixis has partnered with Merck to study zanzalintinib in combination with Keytruda for head and neck squamous cell carcinoma [12][13].