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.)
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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.
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NEWS HIGHLIGHTSMedia Articles Related to Avastin (Bevacizumab)
World's First Delivery Of Intra-Arterial Avastin Directly Into Brain Tumor
Source: Cancer / Oncology News From Medical News Today [2009.11.18]
Neurosurgeons from NewYork-Presbyterian Hospital/Weill Cornell Medical Center performed the world's first intra-arterial cerebral infusion of Avastin (bevacizumab) directly into a patient's malignant brain tumor. This novel intra-arterial (IA) technique may expose the cancer to higher doses of the drug therapy, while possibly sparing the patient common side effects of receiving the drug intravenously (IV) or throughout their body.
Patient Receives World's First Delivery Of Intra-arterial Avastin Directly Into A Malignant Brain Tumor
Source: Cancer / Oncology News From Medical News Today [2009.11.18]
Neurosurgeons from NewYork-Presbyterian Hospital/Weill Cornell Medical Center performed the world's first intra-arterial cerebral infusion of Avastin (bevacizumab) directly into a patient's malignant brain tumor. This novel intra-arterial (IA) technique may expose the cancer to higher doses of the drug therapy, while possibly sparing the patient common side effects of receiving the drug intravenously (IV) or throughout their body.
Genentech Submits Supplemental Applications To FDA For Avastin Combined With Commonly Used Chemotherapies For Women With Advanced Breast Cancer
Source: Breast Cancer News From Medical News Today [2009.11.17]
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment).
FDA Approves Avastin for Most Common Kidney Cancer
Source: MedicineNet Kidney Cancer Specialty [2009.08.05]
Title: FDA Approves Avastin for Most Common Kidney Cancer
Category: Health News
Created: 8/5/2009 7:00:00 AM
Last Editorial Review: 8/5/2009
Cancer Drug Avastin Raises Blood Clot Risk
Source: MedicineNet thalidomide Specialty [2008.11.19]
Title: Cancer Drug Avastin Raises Blood Clot Risk
Category: Health News
Created: 11/19/2008
Last Editorial Review: 11/19/2008
Published Studies Related to Avastin (Bevacizumab)
Surgery with curative-intent in patients treated with first-line chemotherapy plus bevacizumab for metastatic colorectal cancer First BEAT and the randomised phase-III NO16966 trial. [2009.10.06]
BACKGROUND: Complete resection of metastases can result in cure for selected patients with metastatic colorectal cancer... CONCLUSIONS: The rate of serious post-operative complications in First BEAT was comparable to historical controls without bevacizumab. In NO16966, there were no statistically significant differences in resection rates or overall survival in patients treated with bevacizumab vs placebo.
Bevacizumab vs Ranibizumab for Age-related Macular Degeneration: Early Results of a Prospective Double-Masked, Randomized Clinical Trial. [2009.10.02]
PURPOSE: To report early outcomes of a prospective, double-masked, controlled trial comparing bevacizumab (Avastin; Genentech Inc, South San Francisco, California, USA) to ranibizumab (Lucentis; Genentech Inc) for the treatment of age-related macular degeneration. DESIGN: Prospective, double-masked, randomized clinical trial... CONCLUSION: Early results of a head-to-head, randomized, double-masked, prospective, single-center controlled trial between bevacizumab and ranibizumab show no difference in efficacy between the two treatments for choroidal neovascularizaton in the treatment of age-related macular degeneration. As this study conveys results of a small number of patients, further studies with larger sample sizes are needed in order to establish statistical significance.
Intravitreal bevacizumab for neovascular glaucoma: a randomized controlled trial. [2009.10]
PURPOSE: To determine the effect of intravitreal bevacizumab (IVB) on neovascular glaucoma (NVG) in terms of iris neovascularization (NVI), intraocular pressure (IOP), and visual acuity... CONCLUSIONS: Intravitreal injections of bevacizumab seem to reduce NVI and IOP in NVG and may be considered as an adjunct to more definitive surgical procedures for NVG.
Intravitreal bevacizumab for prevention of early postvitrectomy hemorrhage in diabetic patients: a randomized clinical trial. [2009.10]
OBJECTIVE: To evaluate the effect of preoperative intravitreal bevacizumab (IVB) injection on the rate of early (< or =4 weeks) postvitrectomy hemorrhage in patients with proliferative diabetic retinopathy (PDR). DESIGN: Prospective, randomized, double-masked clinical trial. PARTICIPANTS: Sixty-eight eyes of 68 patients undergoing pars plana vitrectomy for management of PDR complications... CONCLUSIONS: Intravitreal injection of bevacizumab 1 week before vitrectomy seems to reduce the incidence of early postvitrectomy hemorrhage in diabetic patients. The need for vitrectomy also may be decreased significantly in these cases.
Initial safety report of NSABP C-08: A randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer. [2009.07.10]
PURPOSE: The National Surgical Adjuvant Breast and Bowel Project C-08 trial was designed to investigate the safety and effectiveness of adding bevacizumab to modified infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) 6 regimen for the adjuvant treatment of patients with stage II or III colon cancer. We present safety information in advance of the planned analysis of efficacy... CONCLUSION: Bevacizumab with modified FOLFOX6 is well tolerated in the surgical adjuvant setting in these patients. No significant increase in GI perforation, hemorrhage, arterial or venous thrombotic events, or death with the addition of bevacizumab to modified FOLFOX6 has been observed. Follow-up for potential delayed adverse effects and efficacy is ongoing.
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.
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Page last updated: 2009-11-18
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