Translate
Subscribe to Blog via Email
Ronny Allan
What is Everolimus (Afinitor)?
Manufactured by Novartis, this is a targeted biological therapy or more accurately, a mammalian Target of Rapamycin (mTOR) inhibitor. It works by stopping some of the signals within cells that make them grow and divide. Everolimus stops a particular protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. So everolimus helps to stop the cancer growing or may slow it down. The drug is also approved for Renal Cell Carcinoma (RCC) and hormone-receptor-positive advanced Breast Cancer.
The drug is administered in oral form (tablet). The recommended dose for AFINITOR® (everolimus) Tablets is one 10-mg tablet once daily but lower doses of 7.5-mg tablets, 5-mg tablets, and 2.5-mg tablets are available if dose adjustment is required for adverse events, drug interactions, and hepatic impairment.
Who can get Everolimus (Afinitor)?
The USA Food and Drug Administration approved everolimus (Afinitor, Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.
Europe Medicines Agency (EMA) approved the drug for pancreatic neuroendocrine tumours when the cancer cells are well- or (sic) moderately differentiated* and the cancer is progressing or unresectable. Also approved for neuroendocrine tumours originating in the lungs or gut, when the cancer cells are well-differentiated and the cancer is metastatic or unresectable.
UK‘s drug approval NICE states that Everolimus is recommended as options for treating well- or (sic) moderately differentiated* unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease. Also, as an option for treating well-differentiated (grade 1 or grade 2**) non-functional unresectable or metastatic NETs of gastrointestinal or lung origin in adults with progressive disease. the NICE recommendation also states that Everolimus is recommended only when the company provides it with the discount agreed in the patient access scheme.
* moderately differentiated is not a term included in the World Health Organisation classification system for Neuroendocrine Neoplasms – read more about this here.
** since approval, there is now a Grade 3 well-differentiated category, but it is not clear if the drug automatically becomes available for use on Grade 3 NETs.
Other countries as per their own marketing authorisations and approvals.
The efficacy and safety of everolimus was demonstrated in the RADIANT trials:
RADIANT-1. This trial assessed the efficacy and safety of everolimus in patients with metastatic pancreatic NET
RADIANT-2. This trial looked at everolimus in patients with low grade NET plus carcinoid syndrome.
RADIANT-3. Mainly looking at comparing everolimus as a first line treatment in pancreatic NETs vs a later treatment line).
RADIANT-4. The RADIANT 4 trial was the first randomized study to show that everolimus is effective in patients with pulmonary NETs.
Technical Information on Everolimus (Afinitor)
Read more on the manufacturer’s website – click here. Specifically:
Important safety information and side effects:
Pancreatic NETs – click here.
Progressive, Non-functional GI and Lung Neuroendocrine Tumors (NET) – click here
Are there any extant clinical trials for Everolimus?
Check out this link filtered for trials awaiting or recruiting using keyword “Everolimus” and “Neuroendocrine Tumors” – click here. Due to the vagaries of the Clinical Trials database, the filter isn’t perfect. I carefully selected a few as I’ve seen these pop up in my feed plus mentioned a conferences:
1. Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE) – I wrote about this trial already and everolimus forms a combo approach – click here.
2. Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable NETs (TALENT) I’ve previously written about Lenvatinib – click here
Disclaimer: Taking part in a clinical trial is a big decision and must be considered carefully in conjunction with your healthcare professionals and close family. Mention of any clinical trial on RonnyAllan.NET is not a recommendation to participate.
Are there any patient support programmes for Everolimus?
Where applicable, yes – click here.
Summary
Everolimus (Afinitor) remains a tool in the NET treatment arsenal and is also being used in combo treatment trials.
Disclaimer. Ronny Allan has received no financial payment from Novartis for producing this post and the content does not constitute a recommendation to use any of their products.
Disclaimer
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.
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.
Top 10 Posts & Pages in the last 48 hours (auto updates) (Click the titles to read them)
Thanks for reading.
Personal Facebook. Like this page please.
Blog Facebook. Like this page please.
Awareness Facebook Like this page please.
Sign up for my newsletters – Click Here
My Diagnosis and Treatment History
Check out my online presentations
Check out my WEGO Health Awards
Check out my Glossary of Terms – click here
Please Share this post for Neuroendocrine Cancer awareness and to help another patient
Never mind the Bollocks – here’s the cancer
I don’t tend to share some very personal stuff, but this is on the boundary of that rule and there are some important messages to
First and only FDA-cleared, fully automated chromogranin A assay
There has been controversy about the utility of Chromogranin A for many years now. Specialists have been critical about its use but to be fair
Neuroendocrine Cancer: Question, Clarify, Confirm
One of the many observations I make in my private Neuroendocrine Cancer Facebook group is the misunderstandings caused by the use of non-standard terminology combined
Clinical Trial – Lutathera NETTER-2 Important Update
UPDATE – Sep 25th, 2023 – Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors
Lanreotide: Ipsen injection devices vs generic injection devices
Whenever I get a chance to talk to a pharma involved in somatostatin analogue injection devices, I tell them one very important thing …… “To
Cancer doesn’t take holidays (but I do)
Glen Etive Scotland in 2018 After diagnosis in July 2010, with the exception of a planned holiday to Turkey prior to my ‘big surgery’, holidays
Update from Ronny Allan: No evidence of progressive disease at any site
Update August 2023. Latest CT surveillance scan reports “No evidence of progressive disease at any site”. Very pleased! With incurable but treatable cancers such as
Exercise is Medicine
Exercise is medicine. Clearly I need to be careful with that statement given my aversion for cancer myths. However, those who know me will totally
Jimmy Buffett 1946-2023 – Neuroendocrine Carcinoma (Merkel Cell Carcinoma)
US singer-songwriter Jimmy Buffett, best known for his 1970’s hit Margaritaville, has died aged 76. “Jimmy passed away peacefully on the night of September 1
A cup of tea
I would also mention those who contributed to my “Tea Fund” which resides on PayPal. You don’t need a PayPal account as you can select a card but don’t forget to select the number of units first (i.e. 1 = £4, 2 = £8, 3 = £12, and so on), plus further on, tick a button to NOT create a PayPal account if you don’t need one. Clearly, if you have a PayPal account, the process is much simpler
Through your generosity, I am able to keep my sites running and provide various services for you. I have some ideas for 2023 but they are not detailed enough to make announcements yet.
This screenshot is from every single post on my website and depending on which machine you are using, it will either be top right of the post or at the bottom (my posts are often long, so scroll down!)
