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– CABOMETYX reduced the risk of disease progression or death by 81% versus placebo in patients with advanced lung or thymic neuroendocrine tumors (NET) –
– The lungs are the second most common NET site of origin, yet limited treatment options are available
Read announcement from Exelixis here.
This does not mean the drug is available right now.
“This U.K. marketing authorisation marks a critical milestone in making a licensed and efficacious treatment option available to patients upon progression. We are actively engaging with the National Institute for Health and Care Excellence (NICE) to ensure that individuals living with this often overlooked form of cancer in the U.K. have timely access to this approved therapeutic option,” said Dr Ian Gray, U.K. & Ireland Interim Medical Director at Ipsen.
Cabozantinib has been submitted for review by NICE, with a decision expected later in 2025. I will keep you updated as usual.
Read announcement from Ipsen here
Cabometyx® is the first and only systemic therapy approved in the European Union for previously treated neuroendocrine tumours, regardless of tumour site, grade or previous non-somatostatin analogue-based systemic therapy
In the meantime, I would advise anyone not in USA, to contact their doctors asking about any potential access prior to national approvals. I have anecdotal evidence this is already happening in the Netherlands.
Read announcement from Ipsen here.
Jennifer Chan, MD, MPH, highlights the significance of the FDA approval of cabozantinib for the treatment of patients with pNET and epNET.
FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET
On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
What is this drug prescribed for?
Full prescribing information for Cabometyx (Cabozantinib) for pNET and epNET is click here.
What do I need to know including insurance and financial support? (US patients)
The patient handbook produced by Exelixis can be found by clicking here – this should answer queries including financial support and insurance.
Please note the use of the term ‘Extrapancreatic Neuroendocrine Tumors’. It simply means something that originates outside of the pancreas.
Yes. When you update yourself below and note the wording from the manufacturer above, it becomes evident that Cabozantinib is probably not a first line treatment. Rather it is a tool to be used downstream after current treatments still result in progression. The trial was based on those with advanced Neuroendocrine Tumours. During that trial, cabozantinib, as compared with placebo, was used on those that had progressed after previous therapy with Lu-177 dotatate or targeted agents, including everolimus or sunitinib. The output data looks like it is a great option for those in that position and offers hope.
Please note the use of the term ‘Extrapancreatic Neuroendocrine Tumors’. It simply means something that originates outside of the pancreas.
There has been a tremendous amount of postings about this drug since the phase 3 trial sponsors produced their initial data. Since then there has been a Supplemental New Drug Application (sNDA) for Cabozantinib for Patients with Advanced Neuroendocrine Tumors. The FDA assigned a Prescription Drug User Fee Act target action date of April 3, 2025 (i.e. a new or amended approval will be decided by then). The sNDA Application is based on results from the phase 3 CABINET pivotal trial, in which cabozantinib provided a statistically significant and clinically meaningful improvement in progression-free survival versus placebo. Cabozantinib, as compared with placebo, significantly improved progression-free survival in patients with previously treated, progressive advanced extrapancreatic or pancreatic neuroendocrine tumors. Adverse events were consistent with the known safety profile of cabozantinib. (Funded by the National Cancer Institute and others; CABINET ClinicalTrials.gov number, NCT03375320.) An excellent summary of the final data can be found on the manufacturers website – See Reference 2 below. For those with access to The New England Journal of Medicine, you may be able to access the full report here.
You may be wondering why Ipsen is involved? I also discovered that there is an exclusive licensing Agreement with the manufacturers (Exelixis) and Ipsen (of Lanreotide fame) to commercialize and develop Cabozantinib in regions outside the United States and Japan Also, for Europeans, Ipsen has submitted an extension of the Marketing Authorization to the European Medicines Agency (EMA) which means the drug could potentially be approved in Europe with a similar timescale to the US FDA sNDA above. Lets hope so.
Cabozantinib is an oral drug which works by blocking the growth of new blood vessels that feed a tumour. In addition to blocking the formation of new blood cells in tumours, Cabozantinib also blocks pathways that may be responsible for allowing cancers cells to become resistant to other “anti-angiogenic” drugs. It is a type of drug called a growth blocker. Cabozantinib has been studied or is already in research studies as a possible treatment for various types of cancer, including prostate cancer, ovarian cancer, brain cancer, thyroid cancer, lung cancer, and kidney cancer. Also known by the brand name of Cabometyx®
Growth blockers are a type of targeted therapy and include tyrosine kinase inhibitors, proteasome inhibitors, mTOR inhibitors, PI3K inhibitors, histone deacetylase inhibitors and hedgehog pathway blockers. Cabozantinib is a tyrosine kinase inhibitor (TKI). They block chemical messengers (enzymes) called tyrosine kinases. Tyrosine kinases help to send growth signals in cells so blocking them stop the cell growing and dividing. Some TKIs can block more than one tyrosine kinase and these are known as multi-TKIs.
So Cabozantinib is a targeted therapy and growth blocker just like Everolimus (Afinitor) and Sunitinib (Sutent). Very technical process but in the simplest of terms, Cabozantinib is designed to disrupt the actions of VEGF (a growth factor) and MET (a growth factor receptor) which promote spread of cancerous cells through the growth of new blood vessels. Whilst we are on this subject, please note Everolimus (Afinitor) is an mTOR inhibitor and Sunitinib (Sutent) is a tyrosine kinase inhibitor. Many people think these drugs are a type of chemo – that is incorrect, these are targeted therapies. See more on this by clicking here.
During my research, I found that it is an existing drug approval for other cancers and even has a connection to a type of Neuroendocrine Cancer called Medullary Thyroid Cancer (MTC). Cabozantinib, under the brand name of ‘Cometriq’ was approved by the FDA in 2012 for use in MTC which is frequently associated with Multiple Endocrine Neoplasia 2 (MEN2). Read more about Cometriq here. It’s also been approved by the FDA for advanced renal cell carcinoma (RCC) (branded as Cabometyx).
The history of the latest clinical trial can be found below.
1. Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors | New England Journal of Medicine (nejm.org)
2.Exelixis Announces Final Results from Phase 3 Pivotal CABINET Study Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2024 and Published in New England Journal of Medicine | Exelixis, Inc.
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional. Some content may be generated by AI which can sometimes be misinterpreted. Please check any references attached.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
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