FDA Expands Exelixis Cabometyx Label for Neuroendocrine Tumors

Exelixis, Inc. EXEL announced that the FDA has approved the label expansion of its lead drug Cabometyx (cabozantinib).The regulatory body approved Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET).Simultaneously, the drug was approved for adult and pediatric patients (12 years of age and older) with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).Consequently, Cabometyx is now the first and only systemic treatment that is FDA-approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression and functional status.The approval came ahead of the target action date of April 3, 2025.More on EXEL’s CabometyxCabometyx is one of the leading tyrosine kinase inhibitor (TKI) for the treatment of renal cell carcinoma (RCC) in both the frontline immuno-oncology (IO) +TKI market and the second-line monotherapy segment.We note that Cabometyx has also been approved for use in combination with Bristol Myers’ BMY Opdivo in the first-line setting in RCC. BMY’s Opdivo is one of the leading IO drugs, and it has been approved for various oncology indications.Cabometyx is also approved for the treatment of hepatocellular carcinoma.The drug is approved for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.The latest FDA approval is based on results from the phase III CABINET study, which evaluated Cabometyx compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET.Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to placebo.NET are mostly heterogeneous tumors that originate from the neuroendocrine cells of the digestive tract and other organs, such as the lung and pancreas. The patients diagnosed with the disease at an advanced stage face a poor prognosis.The label expansion of Cabometyx is expected to boost sales of the drug, which reached $1.8 billion in 2024.EXEL Makes Encouraging Pipeline ProgressThe pipeline progress has been impressive as well, as Exelixis looks to expand its oncology portfolio beyond Cabometyx.The company is now focused on developing zanzalintinib, a next-generation oral TKI. In January 2025, results from an expansion cohort of the phase Ib/II STELLAR-001 study evaluating zanzalintinib alone or in combination with Tecentriq (atezolizumab) in patients with previously treated metastatic colorectal cancer (CRC) were presented. The data support zanzalintinib’s ongoing pivotal development in metastatic CRC.  Exelixis' pipeline also includes other pipeline candidates — XL495, XL309 (potentially the best-in-class small molecule inhibitor of USP1) and XB010 (a 5T4-targeting antibody-drug conjugate).The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug, Cabometyx.Shares of Exelixis have risen 11.1% year to date compared with the industry’s growth of 4.7%.Image Source: Zacks Investment ResearchThe company's upbeat performance can be attributed to its strong quarterly results, raised guidance and efforts to increase shareholders' returns.On Feb. 20, its board of directors authorized the repurchase of up to an additional $500 million of the company’s common stock before Dec. 31, 2025. This is the fourth such program undertaken by the company since March 2023. Shares rallied post the announcement.EXEL’s Zacks Rank and Stocks to ConsiderEXEL currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the pharma/biotech sector are Bayer BAYRY and Novo Nordisk NVO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.BayerIn the past 30 days, Bayer’s earnings per share (EPS) estimate for 2025 has increased to $1.19 from $1.14. During the same timeframe, the figure for 2026 has increased to $1.28 from $1.23. Shares of BAYRY have surged 25.5% in the past three months.NVOIn the past 30 days, NVO’s EPS estimate for 2025 has increased to $3.93 from $3.84. During the same timeframe, the figure for 2026 has increased to $4.82 from $4.66. Only $1 to See All Zacks' Buys and SellsWe're not kidding.Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Novo Nordisk A/S (NVO): Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report Exelixis, Inc. (EXEL): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks