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FDA Expands Exelixis Cabometyx Label for Neuroendocrine Tumors
EXELExelixis(EXEL) ZACKS·2025-03-27 20:00

Core Insights - Exelixis, Inc. announced FDA approval for the label expansion of its lead drug Cabometyx for treating adult and pediatric patients aged 12 and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumors (pNET) [1] - Cabometyx is now the first and only systemic treatment FDA-approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression, and functional status [2] - The approval was based on results from the phase III CABINET study, which showed significant improvement in progression-free survival compared to placebo [6] Drug Performance and Market Impact - Cabometyx sales are projected to reach 1.8billionin2024,withthelabelexpansionexpectedtofurtherboostsales[7]−Thedrugisalsoapprovedforotherindications,includingrenalcellcarcinoma(RCC)andhepatocellularcarcinoma,enhancingitsmarketpresence[4][5]PipelineDevelopment−ExelixisisadvancingitsoncologyportfoliobeyondCabometyx,focusingondevelopingzanzalintinib,anext−generationoralTKI[9]−Thecompanyhasotherpipelinecandidates,includingXL495,XL309,andXB010,whichcoulddiversifyitsofferingsandreducedependenceonCabometyx[10][11]FinancialPerformance−Exelixisshareshaveincreasedby11.11.8 billion in 2024, with the label expansion expected to further boost sales [7] - The drug is also approved for other indications, including renal cell carcinoma (RCC) and hepatocellular carcinoma, enhancing its market presence [4][5] Pipeline Development - Exelixis is advancing its oncology portfolio beyond Cabometyx, focusing on developing zanzalintinib, a next-generation oral TKI [9] - The company has other pipeline candidates, including XL495, XL309, and XB010, which could diversify its offerings and reduce dependence on Cabometyx [10][11] Financial Performance - Exelixis shares have increased by 11.1% year-to-date, outperforming the industry growth of 4.7% [13] - The company has authorized a stock repurchase program of up to 500 million, indicating strong financial health and commitment to shareholder returns [14]