Avastin (bevacizumab)Company: Genentech
Approval Status: Approved July 2009
Treatment for: renal cell carcinoma
Areas: Urology & Kidneys; Cancer & Oncology
Possible similar drugs: Avastin
Avastin (bevacizumab) is a humanized antibody to vascular endothelial growth factor (VEGF).
Avastin is specifically indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
Avastin is supplied as a solution for intravenous administration. The recommended initial dose of the drug for renal cell carcinoma is 10 mg/kg every 2 weeks in combination with interferon alfa.
The FDA approval of Avastin for renal cell carcinoma was based on a multicenter, randomized, double-blind, international study comparing Avastin plus interferon alfa 2a (IFN- a2a) versus placebo plus IFN-a2a. The trial enrolled 649 patients who had undergone a nephrectomy were randomized (1:1) to receive either Avastin (10 mg/kg IV infusion every 2 weeks; n = 327) or placebo (IV every 2 weeks; n = 322) in combination with IFN-a2a (9 MIU subcutaneously three times weekly, for a maximum of 52 weeks). The subjects were treated until disease progression or unacceptable toxicity. The main outcome measure of the study was investigator-assessed progression free survival (PFS). Secondary outcome measures were overall response rate (ORR) and overall survival (OS). PFS was statistically significantly prolonged among patients receiving Avastin plus IFN-a2a compared to those receiving IFN-a2a alone; median PFS was 10.2 months vs. 5.4 months (p-value<0.0001). Among the 595 subjects with measureable disease, ORR was also significantly higher (30% vs. 12% (p < 0.0001). There was no improvement in OS based on the final analysis conducted after 444 deaths, with a median OS of 23 months in the Avastin plus IFN-a2a arm and 21 months in the IFN-a2a plus placebo arm.
Adverse events associated with the use of Avastin may include, but are not limited to, the following:
- taste alteration
- dry skin
- rectal hemorrhage
- lacrimation disorder
- back pain
- exfoliative dermatitis
Mechanism of Action
Avastin (bevacizumab) is a humanized antibody to vascular endothelial growth factor (VEGF). It binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis.
Literature ReferencesBukowski RM Targeted Therapies: Bevacizumab and interferon-alpha in metastatic renal-cell carcinoma. Nature Reviews. Clinical Oncology 2009 May;6(5):253-4
Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Ou SS, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. Journal of Clinical Oncology : official journal of the American Society of Clinical Oncology 2008 Nov 20;26(33):5422-8
Melichar B, Koralewski P, Ravaud A, Pluzanska A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Delva R, Sevin E, N?grier S, McKendrick J, Santoro A, Pisa P, Escudier B First-line bevacizumab combined with reduced dose interferon-alpha2a is active in patients with metastatic renal cell carcinoma. Annals of oncology : official journal of the European Society for Medical Oncology 2008 Aug;19(8):1470-6
Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007 Dec 22;370(9605):2103-11
Additional InformationFor additional information regarding Avastin or renal cell carcinoma, please visit the Avastin web page.
Avastin Drug Information
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