Therapies

Bevacizumab

Avastin

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SUMMARY

Company: Genentech
Approval Status: FDA Approved July 2009
Specific Treatments: renal cell carcinoma
Drug: Bevacizumab

 

GENERAL INFORMATION

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.

 

CLINICAL RESULTS

FDA Approval

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.

 

SIDE EFFECTS

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

  • epistaxis
  • headache
  • hypertension
  • rhinitis
  • proteinuria
  • 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.

Source: centerwatch