Exelixis Faces FDA Update on Cabozantinib Approval Process
Exelixis, Inc. (EXEL) has received news from the FDA regarding its supplemental new drug application (sNDA) for cabozantinib.
The sNDA aims to gain approval for cabozantinib to treat adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET).
In November 2024, the FDA indicated that the sNDA would be discussed during an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. However, the FDA recently informed Exelixis that the sNDA will no longer be on the agenda for this meeting. It remains under review with a target action date of April 3, 2025.
In the past six months, Exelixis’ shares have surged by 53.2%, surpassing the industry’s decline of 10.1% during the same period.
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Examining EXEL’s sNDA for Cabometyx
The sNDA is supported by the final results from the phase III CABINET pivotal trial, which was conducted by the National Cancer Institute’s National Clinical Trials Network. This trial compared cabozantinib with a placebo in patients with advanced pNET and epNET.
In August 2023, the Alliance for Clinical Trials in Oncology’s independent Data and Safety Monitoring Board recommended halting enrollment in the CABINET trial, allowing patients to switch from placebo to cabozantinib due to a significant improvement in progression-free survival (PFS) seen in interim results. Final results confirmed statistically significant and clinically meaningful improvements in PFS for cabozantinib versus placebo.
Cabozantinib, marketed as Cabometyx, is already approved as a monotherapy for advanced renal cell carcinoma (RCC) and in combination with Opdivo (nivolumab) for first-line treatment of advanced RCC. It is also approved for hepatocellular carcinoma in patients who have been previously treated with sorafenib and for adult and pediatric patients aged 12 and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed after previous VEGFR-targeted therapy.
As of August 2024, cabozantinib received orphan drug designation from the FDA for treating pNET, with the same April 3, 2025 target action date.
Exelixis Seeks to Broaden Cabometyx’s Indications
In the first nine months of 2024, Exelixis reported $1.3 billion in product revenues, largely stemming from Cabometyx sales. A successful label expansion would likely enhance these figures further.
Furthermore, Exelixis is actively working to diversify its oncology portfolio. A notable candidate is zanzalintinib, a next-generation oral TKI. Recently, enrollment was completed in the late-stage STELLAR-303 study, which assesses zanzalintinib in combination with Tecentriq versus regorafenib in patients with metastatic colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient. Preliminary results from this study are anticipated in 2025.
Exelixis has partnered with Merck & Co., Inc. (MRK) to evaluate zanzalintinib with Keytruda (pembrolizumab) in a late-stage study for treating head and neck squamous cell carcinoma (HNSCC). Both companies are also set to study zanzalintinib combined with Merck’s hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) in several trials for RCC.
Under their agreement, Merck will provide Keytruda for a phase III study in previously untreated PD-L1-positive recurrent or metastatic HNSCC sponsored by Exelixis. This successful development of additional therapies could reduce Exelixis’ reliance on Cabometyx.
Zacks Rank & Other Notable Stocks
Currently, Exelixis holds a Zacks Rank #2 (Buy).
Additionally, some well-ranked stocks in the biotech industry include Immunocore Holdings plc (IMCR) and Castle Biosciences, Inc. (CSTL), both rated Zacks Rank #1 (Strong Buy) at present. You can view the complete list of today’s Zacks #1 Rank stocks here.
In the last two months, estimates for Immunocore’s 2024 loss per share improved from $1.18 to $0.94. Additionally, estimates for its 2025 losses were tightened from $1.70 to $1.57.
In its past earnings reports, IMCR beat estimates in two out of the last four quarters, averaging a surprise of 25.57%.
Castle Biosciences’ 2024 loss per share estimates also improved from $0.58 to $0.08 over the last 90 days, with 2025 estimates adjusted from $1.88 to $1.84.
CSTL has consistently beaten earnings estimates for the past four quarters, showing an impressive average surprise of 172.72%.
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Merck & Co., Inc. (MRK): Free Stock Analysis Report
Exelixis, Inc. (EXEL): Free Stock Analysis Report
Castle Biosciences, Inc. (CSTL): Free Stock Analysis Report
Immunocore Holdings PLC Sponsored ADR (IMCR): Free Stock Analysis Report
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