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Everolimus (Afinitor) tablets
Everolimus inhibits mTOR (mammalian target of rapamycin), a protein kinase that controls cell growth and proliferation.
Everolimus inhibits mTOR (mammalian target of rapamycin), a protein kinase that controls cell growth and proliferation. Used for Advanced renal cell carcinoma, Advanced pancreatic neuroendocrine tumors, Hormone receptor-positive, HER2-negative advanced breast cancer.
At a glance
| Generic name | Everolimus (Afinitor) tablets |
|---|---|
| Sponsor | Exelixis |
| Drug class | mTOR inhibitor |
| Target | mTOR (mTORC1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Everolimus is an mTOR inhibitor that blocks the mTORC1 signaling pathway, which regulates cell cycle progression and protein synthesis. By suppressing this pathway, it reduces tumor cell proliferation and angiogenesis. It is used in oncology to treat various cancers where mTOR pathway activation drives tumor growth.
Approved indications
- Advanced renal cell carcinoma
- Advanced pancreatic neuroendocrine tumors
- Hormone receptor-positive, HER2-negative advanced breast cancer
- Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Common side effects
- Stomatitis/mouth ulcers
- Infections
- Fatigue
- Diarrhea
- Rash
- Anemia
- Hyperglycemia
- Hyperlipidemia
- Pneumonitis
Key clinical trials
- Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors (PHASE2, PHASE3)
- Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE) (PHASE1, PHASE2)
- Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (PHASE3)
- European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (PHASE1, PHASE2)
- A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma (PHASE2)
- Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations (PHASE2, PHASE3)
- A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) (PHASE3)
- PNOC 001: Phase II Study of Everolimus for Recurrent or Progressive Low-grade Gliomas in Children (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |