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news.The US Food and Drug Administration (FDA) has granted approval to Exelixis' Cabometyx (cabozantinib) for treating specific types of advanced neuroendocrine tumours (NET) in both adult and paediatric patients aged 12 and older.
The safety profile of Cabometyx in the trial was consistent with its known safety profile. Credit: Darko Stojanovic from Pixabay.
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The FDA’s approval adds to its five prior approvals and is based on positive outcomes from the CABINET Phase III trial.
CABINET is a multicentre, randomised, double-blinded, placebo-controlled trial sponsored by the National Cancer Institute (NCI).
It was carried out by the NCI-funded Alliance for Clinical Trials in Oncology and was part of a Cooperative Research and Development Agreement with the NCI’s Cancer Therapy Evaluation Program.
The trial enrolled 298 patients across the US and included two separately powered cohorts, one for pancreatic neuroendocrine tumours (pNET) and one for extra-pancreatic NET (epNET), with primary tumour sites including the gastrointestinal tract, lung and other organs.
The primary endpoint was progression-free survival (PFS) as per RECIST 1.1 criteria, assessed by blinded independent central review. Secondary endpoints included overall survival, objective response rate and safety.
Exelixis said that the safety profile of Cabometyx in the CABINET trial was consistent with its known safety profile, with no new safety signals identified.
Cabometyx has now been approved for use in individuals with well-differentiated pNET and epNET that are unresectable, locally advanced, or metastatic and have been previously treated.
In the US, the tablets are approved for various advanced cancers, including renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and differentiated thyroid cancer (DTC), in addition to the newly approved indications for pNET and epNET.
Exelixis retains exclusive rights to develop and commercialise within the US.
Exelixis chief medical officer, product development & medical affairs, executive vice-president Amy Peterson said: “Looking forward, we are doubling down on our commitment to the NET community as we prepare to initiate our STELLAR-311 pivotal trial examining zanzalintinib versus everolimus in the first half of 2025.”
