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Home » Drug Information » FDA Approved Drugs » 2011
Medical Areas: Endocrinology | Gastroenterology | Oncology | Family Medicine | Infections and Infectious Diseases

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Afinitor (everolimus)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Novartis
Approval Status: Approved May 2011
Treatment Area: advanced pancreatic neuroendocrine tumors

General Information

Afinitor (everolimus) is an antineoplastic agent that works by inhibiting mammalian target of rapamycin (mTOR), a protein kinase that regulates cell growth, proliferation, motility and survival. The mTOR pathway is dysregulated in several human cancers. Inhibition of mTOR by everolimus has been shown to reduce cell proliferation, angiogenesis, and glucose uptake in in vitro and/or in vivo studies.

Afinitor is specifically approved for the treatment of progressive neuroendocrine tumors of pancreatic origin in patients with unresectable, locally advanced or metastatic disease.

Afinitor is supplied as a tablet for oral administration. The recommended dose of Afinitor for pancreatic cancer is is 10 mg once daily.

Clinical Results

FDA Approval
The FDA approval of Afinitor for pancreatic cancer was based on a randomized, double-blind, multi-center trial in 410 subjects with locally advanced or metastatic advanced pancreatic neuroendocrine tumors and disease progression within the prior 12 months. The subjects received either Afinitor 10 mg/day or placebo until disease progression. The primary endpoint was progression-free survival (PFS) evaluated by RECIST (Response Evaluation Criteria in Solid Tumors). The trial demonstrated a statistically significant improvement in PFS (median 11.0 months versus 4.6 months), resulting in a 65% risk reduction in investigator-determined PFS.

Side Effects

Adverse events associated with the use of Afinitor may include, but are not limited to, the following:

  • stomatitis
  • rash
  • diarrhea
  • fatigue
  • edema
  • abdominal pain
  • nausea
  • fever
  • headache

Mechanism of Action

Afinitor (everolimus) is an inhibitor of mammalian target of rapamycin (mTOR). mTOR is a serine/threonine protein kinase that regulates cell growth, cell proliferation, cell motility, cell survival, protein synthesis, and transcription. The mTOR pathway is dysregulated in several human cancers. Inhibition of mTOR by everolimus has been shown to reduce cell proliferation, angiogenesis, and glucose uptake in in vitro and/or in vivo studies.

Literature References

Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Öberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group Everolimus for advanced pancreatic neuroendocrine tumors. New England Journal of Medicine 2011 Feb 10;364(6):514-23

Additional Information

For additional information regarding Afinitor or pancreatic neuroendocrine tumors, please visit the Afinitor web page.