Avastin (bevacizumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 2014

Specific Treatments:

persistent, recurrent, or metastatic cervical cancer

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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/