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Avastin (Bevacizumab) - Summary

 
 



WARNINGS

GASTROINTESTINAL PERFORATIONS

AVASTIN administration can result in the development of gastrointestinal perforation, in some instances resulting in fatality. Gastrointestinal perforation, sometimes associated with intra‑abdominal abscess, occurred throughout treatment with AVASTIN (i.e., was not correlated to duration of exposure). The incidence of gastrointestinal perforation (gastrointestinal perforation, fistula formation, and/or intra‑abdominal abscess) in patients with colorectal cancer and in patients with non‑small cell lung cancer (NSCLC) receiving AVASTIN was 2.4% and 0.9%, respectively. The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting. Gastrointestinal perforation should be included in the differential diagnosis of patients presenting with abdominal pain on AVASTIN. AVASTIN therapy should be permanently discontinued in patients with gastrointestinal perforation. (See WARNINGS: Gastrointestinal Perforations and DOSAGE AND ADMINISTRATION: Dose Modifications.)

WOUND HEALING COMPLICATIONS

AVASTIN administration can result in the development of wound dehiscence, in some instances resulting in fatality. AVASTIN therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of AVASTIN and subsequent elective surgery required to avoid the risks of impaired wound healing⁄wound dehiscence has not been determined. (See WARNINGS: Wound Healing Complications and DOSAGE AND ADMINISTRATION: Dose Modifications.)

Hemorrhage

Fatal pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and AVASTIN. The incidence of severe or fatal hemoptysis was 31% in patients with squamous histology and 2.3% in patients with NSCLC excluding predominant squamous histology. Patients with recent hemoptysis (≥1⁄2 tsp of red blood) should not receive AVASTIN. (See WARNINGS: Hemorrhage, ADVERSE REACTIONS: Hemorrhage, and DOSAGE AND ADMINISTRATION: Dose Modifications.)

 

AVASTIN SUMMARY

AVASTIN® (Bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity‑determining regions of a murine antibody that binds to VEGF (1).

AVASTIN®, in combination with intravenous 5‑fluorouracil‑based chemotherapy, is indicated for first- or second‑line treatment of patients with metastatic carcinoma of the colon or rectum.

AVASTIN®, in combination with carboplatin and paclitaxel, is indicated for first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.


See all Avastin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Avastin (Bevacizumab)

A randomized trial of bevacizumab for newly diagnosed glioblastoma. [2014]
patients with newly diagnosed glioblastoma is not known... CONCLUSIONS: First-line use of bevacizumab did not improve overall survival in

TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. [2013]
specifically activates death receptor 5 (DR5)... CONCLUSIONS: Conatumumab with mFOLFOX6/bev did not offer improved efficacy over

ATLAS: randomized, double-blind, placebo-controlled, phase IIIB trial comparing bevacizumab therapy with or without erlotinib, after completion of chemotherapy, with bevacizumab for first-line treatment of advanced non-small-cell lung cancer. [2013]
regimen with bevacizumab for advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: The addition of erlotinib to bevacizumab significantly improved PFS

Treatment rationale and study design for a randomized, double-blind, placebo-controlled phase II study evaluating onartuzumab (MetMAb) in combination with bevacizumab plus mFOLFOX-6 in patients with previously untreated metastatic colorectal cancer. [2013]
BACKGROUND: Dysregulation of the hepatocyte growth factor (HGF)/MET pathway is associated with poor prognosis, more aggressive biological characteristics of the tumor, and shortened survival in patients with metastatic colorectal cancer (mCRC)... Correlative studies will be performed on tissue- and blood-derived biomarkers related to both HGF/MET signaling and other associated pathway markers.

Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab. [2013]
CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a

more studies >>

Clinical Trials Related to Avastin (Bevacizumab)

MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen [Recruiting]
The first results of Anti Vascular Endothelial Growth Factor (VEGF) therapy were very promising and superior to established therapies. Three different substances all of them applied intravitreally are available, but comparative studies have not yet been conducted. In this pilot study the safety (number of adverse events)and efficacy (distance acuity testing retinal thickness measurement)of Avastin and Macugen applied as monotherapy should be compared to a combined treatment of Avastin followed by macugen used for retreatment.

At least equal results of the combined therapy are expected.

A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin) [Active, not recruiting]
This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial.

In addition, this study will provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME.

Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma [Active, not recruiting]
The purpose of this study is to determine whether the combination of the investigational drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously been treated with chemotherapy.

A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma [Completed]
The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.

A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer [Terminated]
This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. The study is designed to compare the efficacy of these two treatment sequences with respect to progression free survival (PFS) and overall survival.

more trials >>

Reports of Suspected Avastin (Bevacizumab) Side Effects

Death (741)Disease Progression (373)Diarrhoea (250)Nausea (230)Hypertension (209)Vomiting (207)Fatigue (156)General Physical Health Deterioration (149)Anaemia (139)Decreased Appetite (132)more >>


Page last updated: 2014-11-30

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