Exelixis Secures FDA Approval for CABOMETYX® in Advanced Neuroendocrine Tumours
Thursday, March 27, 2025
Exelixis has announced that the United States Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the treatment of adult and paediatric patients aged 12 years and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumours (pNET) and extra-pancreatic neuroendocrine tumours (epNET).
Neuroendocrine tumours (NET) are a diverse group of cancers originating from neuroendocrine cells in various organs, including the digestive tract, lungs, and pancreas. Patients with advanced NET often face poor prognoses due to limited treatment options.
CABOMETYX is already approved as a treatment for advanced renal cell carcinoma (RCC), either as a monotherapy or in combination with nivolumab for first-line treatment.
It is also indicated for patients with hepatocellular carcinoma (HCC) previously treated with sorafenib and for locally advanced or metastatic differentiated thyroid cancer (DTC) following prior VEGFR-targeted therapy.
CABOMETYX has received regulatory approvals in over 65 countries outside the United States and Japan, including the European Union.
The approval is based on data from the CABINET phase 3 trial, which evaluated CABOMETYX in patients with previously treated advanced pNET and epNET.
The safety profile of CABOMETYX observed in the CABINET trial was consistent with previous studies, with no new safety concerns identified.
However, hypertension was reported at a higher incidence in NET patients compared to those with other approved indications. Most patients required dose adjustments or reductions to manage adverse effects.
Exelixis has granted Ipsen Pharma SAS exclusive rights for the commercialisation and further clinical development of cabozantinib outside the United States and Japan, while Takeda Pharmaceutical Company Limited holds exclusive rights for Japan.
Exelixis retains the exclusive rights to develop and commercialise the drug within the United States.
Exelixis plans to initiate the STELLAR-311 pivotal trial in the first half of 2025 to compare zanzalintinib with everolimus in patients with advanced NET.
Source: exelixis.com
