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 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.
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