November 18, 2011 the FDA revoked its approval for Avastin to be used in breast cancer patients. Previously approved for use based on predictions that Avastin would prolong life between 5 and 6 months were proved incorrect with further study. The further study showed Avastin did not prolong life or improve quality of life.
What is Avastin?
Avastin (Bevacizumub) is a monoclonal antibody by Genentech/Roche. It is a humanized monoclonal antibody used to block angiogenesis by blocking vascular endothelial growth factor-A (VEGF-A)
A monoclonal antibody is a mono specific antibody, which means identical immune cells that are cloned by a unique parent cell and are affinity for the same antigen make it.
Angiogenesis is the growth of new blood vessels from pre-existing vessels.
Basically, Avastin blocks the blood supply to the tumor preventing further growth.
What are the approved uses for Avastin?
Avastin was approved in the United States in 2004 for use in metastatic cancers. The drug is approved for the use of treatment in four cancers.
- Metastatic colorectal cancer
- Non-small cell lung cancer
- Metastatic kidney cancer
Doctor may also use Avastin for “off-label” uses. Medications are used “off-label” when the doctor is well informed about the products and has scientific proof of its use. Many medications are used successfully “off-label.”
The FDA’s decision to revoke their approval for Avastin to be utilized in the treatment of breast cancer will affect the patient’s ability to have insurance company approve payment for treatments, but breast cancer patients will still be able to receive Avastin as part of their treatment.
Medicare says it currently has no immediate plan to stop approving payment for use in Medicare receiving breast cancer patients even when used “off-label.”
A macular degeneration eye doctor in Clearwater, Florida, Dana M. Deupree, M.D., uses Avastin “off-label” for eye treatments by injecting the medication into the vitreous humor.
The Macula Center uses Avastin for
- macular edema
- central retina vein occlusion
- diabetic retinopathy
For more information visit the website at: http://www.maculacenter.com/Procedures/Avastin.htm
What are the side effects of Avastin?
Avastin’s most common side effects include:
- Inflammation of the nose
- Increased protein in the urine
- Taste changes
- Dry skin
- Rectal bleeding
- Tear production problems
- Back pain
- Inflammation of the skin.
Avastin can have some serious and possibly fatal side effects.
- Gastrointestinal perforations (signs and symptoms: abdominal pain, nausea, vomiting, constipation and fever)
- Arterial thromboembolic events (heart trouble or strokes)
- Congestive Heart failure
- Proteinuria (increased protein in the urine that can result in kidney problems including nephrotic syndrome.)
- Nervous system disturbances. (Hypertension, seizure, sluggishness, confusion and blindness)