Exelixis, Inc. EXEL announced that the FDA has notified it about an update to its supplemental new drug application (sNDA) for cabozantinib.
The sNDA is seeking approval for cabozantinib for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET).
In November 2024, the FDA notified the company that the sNDA for cabozantinib for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) would be discussed at an Oncologic Drugs Advisory Committee (“ODAC”) meeting in March 2025.
The FDA has now notified the company that its sNDA will no longer be the subject of discussion at the ODAC meeting. The sNDA is under FDA review and has a target action date of April 3, 2025.
Exelixis’ shares have gained 53.2% in the past six months against the industry’s decline of 10.1%.
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More on EXEL’s sNDA for Cabometyx
The sNDA is based on the final results of the phase III CABINET pivotal trial, conducted by the National Cancer Institute's National Clinical Trials Network. The trial evaluated cabozantinib vis-à-vis placebo in advanced pNET and epNET.
In August 2023, the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board unanimously recommended that enrollment in the CABINET trial be stopped and randomized patients be unblinded to therapy with the allowance for crossover from placebo to cabozantinib due to the substantial improvement in progression-free survival (PFS) observed at this interim analysis.
Final results from the enrolled patient population confirmed statistically significant and clinically meaningful improvements with cabozantinib versus placebo in the primary endpoint of PFS by blinded independent central review.
Cabozantinib is approved under the brand name Cabometyx as monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) and in combination with Opdivo (nivolumab) as a first-line treatment for patients with advanced RCC.
The drug is approved for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib, and for adult and pediatric patients aged 12 years and above 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.
In August 2024, the FDA granted cabozantinib orphan drug designation for the treatment of pNET and assigned a target action date of April 3, 2025.
EXEL’s Efforts to Expand Cabometyx Label, Diversify Portfolio
Exelixis generated $1.3 billion in product revenues in the first nine months of 2024, primarily from Cabometyx sales.
A potential label expansion should boost sales further.
The pipeline progress has also been impressive as Exelixis looks to expand its oncology portfolio beyond Cabometyx.
Another promising candidate in Exelixis’ pipeline is zanzalintinib, a next-generation oral TKI. Enrollment has been completed in the late-stage STELLAR-303 study evaluating zanzalintinib, in combination with Tecentriq, compared with regorafenib in patients with metastatic refractory colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient. Preliminary results from the study are expected in 2025.
Exelixis has also collaborated with pharma giant Merck MRK to evaluate zanzalintinib in combination with Merck’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC).
Both the companies will also evaluate zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) in a phase I/II study and two phase III studies for the treatment of patients with RCC.
Per the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1-positive recurrent or metastatic HNSCC.
The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug, Cabometyx.
Zacks Rank & Other Key Picks
EXEL currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Immunocore Holdings plc IMCR and Castle Biosciences, Inc. CSTL, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.18 to 94 cents. Loss per share estimates for 2025 have narrowed from $1.70 to $1.57 during the same time frame.
IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average surprise being 25.57%.
In the past 90 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $1.88 to $1.84 during the same time frame.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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