• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Avastin (bevacizumab)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Avastin (bevacizumab)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Avastin (bevacizumab) is a vascular endothelial growth factor directed antibody.

    Avastin is specifically indicated for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.  

    Avastin is supplied as an injection for intravenous administration. The recommended dose of Avastin is 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan. 

    Clinical Results

    FDA Approval

    The FDA approval of Avastin for persistent, recurrent, or metastatic cervical cancer was based on a randomized, four-arm, multi-center study comparing Avastin with chemotherapy versus chemotherapy alone. A total of 452 patients were randomized (1:1:1:1) to receive paclitaxel and cisplatin with or without Avastin, or paclitaxel and topotecan with or without Avastin. The dosing regimens for Avastin, paclitaxel, cisplatin and topotecan were as follows:

    Day 1: Paclitaxel 135 mg/m2 over 24 hours, Day 2: cisplatin 50 mg/m2 with Avastin;

    Day 1: Paclitaxel 175 mg/m2 over 3 hours, Day 2: cisplatin 50 mg/m2 with Avastin;

    Day 1: Paclitaxel 175 mg/m2 over 3 hours with cisplatin 50 mg/m2 with Avastin;

    Day 1: Paclitaxel 175 mg/m2 over 3 hours with Avastin, Days 1-3: topotecan IV 0.75 mg/m2 over 30 minutes

    Patients were treated until disease progression or unacceptable adverse reactions. The main outcome measure was OS. Results showed an increase in overall survival to 16.8 months in patients who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.

    Side Effects

    Adverse effects 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

    The Avastin drug label comes with the following Black Box Warning: Gastrointestinal Perforations: The incidence of gastrointestinal perforation, some fatal, in patients receiving Avastin ranges from 0.3% to 3%. Discontinue Avastin in patients who develop gastrointestinal perforations. Surgery and Wound Healing Complications: The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in patients receiving Avastin. Discontinue Avastin in patients who develop wound healing complications that require medical intervention. Withhold Avastin at least 28 days prior to elective surgery. Do not administer Avastin for at least 28 days after surgery, and until the wound is fully healed. Hemorrhages: Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding occur up to 5-fold more frequently in patients receiving Avastin. Do not administer Avastin to patients with a recent history of hemoptysis. Discontinue in patients who develop Grade 3-4 hemorrhage.

    Mechanism of Action

    Avastin (bevacizumab) 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. 

    Additional Information

    For additional information regarding Avastin or persistent, recurrent, or metastatic cervical cancer, please visit https://www.avastin.com/

    Approval Date: 2014-08-01
    Company Name: Genentech
    Back to Listings

    Upcoming Events

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    • VaccinewithNeedle-360x240.png

      2021 Vaccine Industry Will Continue to be Dominated by COVID-19 Trials, Experts Say

    • Dominate-360x240.png

      COVID-19, Oncology, CNS and Infectious Disease Trials Will Dominate in 2021, Survey Predicts

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing