EU approves cabozantinib for previously treated neuroendocrine tumors

ALAMEDA, Calif. - Exelixis, Inc. (NASDAQ:EXEL), a pharmaceutical company that has delivered an impressive 100% return to investors over the past year according to InvestingPro data, announced Thursday that its partner Ipsen received European Commission approval for CABOMETYX (cabozantinib) to treat adult patients with unresectable or metastatic neuroendocrine tumors who have progressed following prior therapy other than somatostatin analogues.

The approval applies to both pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors and allows for marketing in all 27 European Union member states, plus Norway, Liechtenstein and Iceland.

The EC decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2025 and is based on results from the phase 3 CABINET trial, which demonstrated statistically significant improvement in progression-free survival versus placebo.

CABOMETYX becomes the first systemic therapy approved in the European Union for previously treated neuroendocrine tumors regardless of tumor site or grade. The drug previously received U.S. Food and Drug Administration approval for similar indications in March 2025.

"The availability of CABOMETYX in the European Union for patients with previously treated advanced neuroendocrine tumors is a significant milestone as there have been limited treatment advancements in the past decade," said Amy Peterson, Executive Vice President and Chief Medical Officer at Exelixis.

Neuroendocrine tumors are cancers that begin in specialized cells of the body’s neuroendocrine system. An estimated 161,000 to 192,000 people in the U.S. are living with unresectable, locally advanced or metastatic NET.

CABOMETYX tablets have received regulatory approvals in over 65 countries outside the U.S. and Japan. Exelixis granted Ipsen exclusive rights for commercialization and clinical development of cabozantinib outside the U.S. and Japan in 2016.

The information in this article is based on a press release statement from Exelixis.

In other recent news, Exelixis is anticipated to report second-quarter earnings that surpass analyst expectations, according to JMP Securities. The firm attributes this to a 7% quarter-over-quarter growth in prescriptions for Exelixis’s cancer drug, cabozantinib. Truist Securities has also raised its price target for Exelixis to $56, citing positive feedback from doctors regarding the launch of its cancer drug Cabometyx for neuroendocrine tumors. Meanwhile, H.C. Wainwright increased its price target to $53, following positive results from Exelixis’s STELLAR-303 phase 3 trial. This trial demonstrated significant improvement in overall survival for patients treated with a combination of zanzalintinib and atezolizumab compared to regorafenib. Despite these developments, UBS maintained a Neutral rating and a $38 price target, expressing caution about the company’s pipeline diversification. Stifel also kept its Hold rating and $38 price target, noting the unexpected positive results from the STELLAR-303 trial. These recent developments highlight the varied analyst perspectives on Exelixis’s financial outlook and strategic direction.

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