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|Title||Afinitor (everolimus) FDA Drug Label|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Everolimus||Afinitor||RAD001|Zortress||mTORC1 Inhibitor 8||Afinitor (everolimus) binds to FKBP-12 and allosterically inhibits mTOR, leading to decreased mTORC1 signaling and potentially resulting in decreased tumor cell growth (PMID: 17766661, PMID: 28400999). Afinitor (everolimus) is FDA approved for use in neuroendocrine tumors of pancreatic, lung or gastrointestinal tract origin, advanced renal cell carcinoma, in adult and pediatric patients aged 1 year and older with tuberous sclerosis complex who have subependymal giant cell astrocytoma, and in combination with Aromasin (exemestane) in hormone receptor-positive, HER2-negative breast cancer (FDA.gov).|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||kidney angiomyolipoma||not applicable||Everolimus||FDA approved||Actionable||In a Phase III trial (EXIST-2) that supported FDA approval, Afinitor (everolimus) treatment resulted in significantly improved response rate (42%, 33/79) compared to placebo (0%, 0/39) in patients with renal angiomyolipoma as a feature of tuberous sclerosis (n=113) or sporadic lymphanioleiomyomatosis (n=5) (PMID: 23312829; NCT00790400).||23312829 detail...|
|Unknown unknown||renal cell carcinoma||not applicable||Everolimus||FDA approved||Actionable||In a Phase III trial (RECORD-1) that supported FDA approval, Afinitor (everolimus) improved progression-free survival (4.0 vs 1.9 months) compared to placebo in patients with metastatic renal cell carcinoma that progressed on other targeted therapies (PMID: 23659703, PMID: 18653228; NCT00410124).||23659703 detail... 18653228|
|Unknown unknown||neuroendocrine tumor||not applicable||Everolimus||FDA approved||Actionable||In a Phase III trial (RADIANT-4) supporting FDA approval, Afinitor (everolimus) treatment significantly improved median progression-free survival (11.0 months) comparing to placebo (3.9 months) in patients with progressive neuroendocrine tumours of the lung or gastrointestinal tract origin (PMID: 26703889; NCT01524783).||detail... 26703889|
|Unknown unknown||subependymal giant cell astrocytoma||not applicable||Everolimus||FDA approved||Actionable||In a Phase III trial (EXIST-1) that supported FDA approval, Afinitor (everolimus) treatment resulted in a 50% or more tumor reduction in 35% (27/78) of adult and pediatric patients diagnosed with tuberous sclerosis complex and had subependymal giant cell astrocytoma, compared to 0% (0/39) in the placebo group (PMID: 23158522; NCT00789828).||23158522 detail...|
|Unknown unknown||islet cell tumor||not applicable||Everolimus||FDA approved||Actionable||In a Phase III trial (RADIANT-3) that supported FDA approval, treatment with Afinitor (everolimus) prolonged progression-free survival (11.0 vs 4.6 months, HR=0.35, p<0.001) compared to placebo in patients with progressive pancreatic neuroendocrine tumors (PMID: 21306238; NCT00510068).||detail... 21306238|