Reference Detail

Ref Type Journal Article
PMID (23659703)
Authors Lebwohl D, Anak O, Sahmoud T, Klimovsky J, Elmroth I, Haas T, Posluszny J, Saletan S, Berg W
Title Development of everolimus, a novel oral mTOR inhibitor, across a spectrum of diseases.
Journal Annals of the New York Academy of Sciences
Vol 1291
Issue
Date 2013 Jul
URL
Abstract Text Everolimus is a potent, oral inhibitor of the mammalian target of rapamycin (mTOR) that has been investigated in multiple clinical development programs since 1996. A unique collaboration between academic and pharmaceutical experts fostered research that progressed rapidly, with simultaneous indication findings across numerous tumor types. Initially developed for the prophylaxis of organ transplant rejection, everolimus has demonstrated efficacy and safety for the treatment of patients with various types of cancer (renal cell carcinoma, neuroendocrine tumors of pancreatic origin, and breast cancer) and for adult and pediatric patients with tuberous sclerosis complex. The FDA approval of everolimus for these diseases has addressed several unmet medical needs and is widely accepted by the medical community where treatment options may be limited. An extensive clinical development program is ongoing to establish the role of everolimus as monotherapy, or in combination with other agents, in the treatment of a broad spectrum of malignancies.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Therapy Description
Drug Name Trade Name Synonyms Drug Classes Drug Description
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 islet cell tumor not applicable Everolimus FDA approved Actionable In a Phase III trial that supported FDA approval, treatment with Afinitor (everolimus) prolonged progression-free survival in patients with pancreatic neuroendocrine tumors (PMID: 23659703). 23659703
Unknown unknown renal cell carcinoma not applicable Everolimus Phase II Actionable In a Phase II clinical trial, Apitolisib (GDC-0980) was inferior to Afinitor (everolimus) by median PFS, 3.7 months (n=42) vs. 6.1 months (n=43), respectively and overall survival trended lower as well in patients with metastatic renal cell carcinoma (PMID: 26951309). 26951309
Unknown unknown renal cell carcinoma not applicable Everolimus FDA approved Actionable In a Phase III trial that supported FDA approval, Afinitor (everolimus) improved progression-free survival in patients with metastatic renal cell carcinoma (PMID: 23659703). 23659703