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An mTOR-blocking pill that doubled progression-free time with exemestane in 2012 and is now paired with the oral SERD giredestrant.
Everolimus is a rapalog that binds FKBP12 and allosterically inhibits mTORC1, a growth-signalling hub downstream of PI3K and AKT. It is approved in HR-positive breast cancer with exemestane after non-steroidal aromatase inhibitor failure, in progressive pancreatic, lung and GI neuroendocrine tumours, and in advanced RCC after sunitinib or sorafenib. BOLERO-2 showed PFS of 7.8 versus 3.2 months for everolimus plus exemestane versus exemestane alone, with no OS benefit; RADIANT-3 and RADIANT-4 showed PFS of 11.0 versus 4.6 and 3.9 months in NETs. Stomatitis (mitigated by dexamethasone mouthwash, SWISH), pneumonitis and hyperglycaemia are the main toxicities. evERA (2025) revived it as the partner of giredestrant after CDK4/6 inhibitors; it is the comparator beaten in LITESPARK-005 and COMPETE. For a newcomer, it is a growth-pathway pill with several niches rather than one dominant use.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Allosteric mTORC1 inhibitor (rapalog) via FKBP12. Connects to PIK3CA / PI3K-alpha and AKT.
1.Everolimus slips into a pocket on PIK3CA / PI3K-alpha.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Generic everolimus is available and inexpensive relative to Afinitor.
Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest. Plans require the generic.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA432 · SMC advice: everolimus. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgery
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Formulation: Pediatric and adult patients with tuberous sclerosis complex for treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection
Confirmed: the accelerated approval of 2010 converted to traditional approval 5.3 years after it was granted.
Formulation: Pediatric and adult patients with tuberous sclerosis complex for treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected
Confirmed: the accelerated approval of 2012 converted to traditional approval 3.4 years after it was granted.
Adults with renal angiomyolipma and tuberous sclerosis complex not requiring immediate surgery
Confirmed: the accelerated approval of 2012 converted to traditional approval 3.8 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2012 | HR+/HER2- advanced breast cancer with exemestane after NSAI failure |
| US | 2011 | Progressive pancreatic NETs |
| US | 2016 | Progressive non-functional lung and GI NETs |
| US | 2009 | Advanced RCC after sunitinib or sorafenib |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Stomatitis | 59% | 8% |
| Pneumonitis | 16% | 3% |
| Hyperglycaemia | 14% | 5% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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VEGF-directed therapy is the default for non-clear cell disease, with everolimus considered in chromophobe tumours; cabozantinib later became preferred for papillary disease.
Everolimus is approved for progressive lung and gastrointestinal neuroendocrine tumours and is a standard option after somatostatin analogues, particularly in lung carcinoids where radioligand therapy is off label.
The thymoma and thymic carcinoma pages follow this guideline for who gets surgery, radiotherapy and chemotherapy; its central message is that these rare tumours should be discussed in an expert network.
Everolimus is a standard option for progressive pancreatic neuroendocrine tumours, alongside sunitinib, chemotherapy and radioligand therapy.
Query for this drug: (TITLE:"Everolimus" OR ABSTRACT:"Everolimus" OR TITLE:"Afinitor" OR ABSTRACT:"Afinitor") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Everolimus, not a curated reading list.
Shares ASPEN: everolimus versus sunitinib in metastatic non-clear cell renal cell carcinoma, Thymic epithelial tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Glucagonoma, VIPoma.
Shares Glucagonoma, VIPoma, Somatostatinoma, COMPETE.
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, Choline metabolism in cancer, PTEN loss.
Shares FKBP12 (FKBP1A), Sirolimus protein-bound particles, Perivascular epithelioid cell tumour (PEComa), mTOR.
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, Choline metabolism in cancer, PTEN loss.
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer, PTEN loss, PI3K, AKT and mTOR inhibitors.
Shares Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus., COMPETE, Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE, Grade 3 well-differentiated neuroendocrine tumour.
Shares Pasireotide, Grade 3 well-differentiated neuroendocrine tumour, Thymoma (WHO types A, AB, B1, B2 and B3), Multiple endocrine neoplasia syndromes (MEN1, MEN2, MEN4).