On December 16, 2010, the U.S. Food and Drug Administration (FDA) recommended the removal of Avastin® from the list of medications to treat advanced breast cancer, citing risks of side effects that outweighed the benefits. Four recently completed clinical trials showed that the drug was not safe and effective in treating this particular cancer. However, Avastin will continue to be approved for treatment of several other types of cancers. The following are some questions and answers related to the FDA's decision on Avastin.
Why is a cancer drug being used to treat an eye disease?
Avastin has two effects: it can block the growth of blood vessels and can make blood vessels less leaky (permeable). As with tumor growth, macular degeneration is characterized by unwanted growth of blood vessels. Avastin cuts-off the blood supply to tumors so they shrink and, in macular degeneration, makes the retina blood vessels less leaky to get rid of the vision-damaging pockets of fluid. Ophthalmologists started using Avastin “off-label” for treatment of macular degeneration before a similar, more expensive drug (Lucentis®) was developed and approved by the same company, Genentech. Off-label use means that a drug isn't specifically approved by the FDA to treat that particular condition, but could be prescribed by doctors if they believe it will benefit their patients. “Avastin is and will continue to be used for treatment of macular degeneration as long as it is on the market for another indication,” says Dr. Jayakrishna Ambati, Professor of Physiology and Professor and Vice-Chair of Ophthalmology and Visual Sciences at the University of Kentucky. An ongoing National Eye Institute-sponsored clinical trial comparing the safety and efficacy of Avastin with that of Lucentis for treating age-related macular degeneration is projected to be completed in February 2012.
What does this FDA recommendation mean for people with wet macular degeneration who currently are being treated with Avastin?
“One of the reasons the FDA is withdrawing approval for the use of Avastin in treating breast cancer is that it has not been shown to be effective for treating this particular cancer,” says Dr. Patricia D'Amore, Professor of Ophthalmology and Pathology at Harvard Medical School, and Co-director of Research, Senior Scientist, and Ankeny Scholar of Retinal Molecular Biology at the Schepens Eye Research Institute. “We already know Avastin is effective in the treatment of leaky blood vessels in wet macular degeneration and will likely remain effective after repeated injections. The big difference between eye pathologies like wet macular degeneration and tumors is that tumor cells have the ability to change over time to attract blood vessels by methods that are not targeted by the effects of Avastin.”
What about the reported risks of Avastin?
The FDA cited risks that include high blood pressure, bleeding, damage to the nose, stomach, and intestines, and heart attack or failure. “To treat macular degeneration, Avastin is delivered by injection into the eye and not to the entire body as is done for cancer. So it is unlikely that the amount of drug that gets into the blood streams of macular degeneration patients would reach the levels that cause these side effects in cancer patients,” says Dr. D'Amore.
It remains the responsibility of each person to decide, with a doctor, the best course of treatment for his/her particular situation. The good news is that Avastin, and other drugs including Visudyne®, Macugen®, and Lucentis, are still available as pharmaceutical options to treat advanced forms of macular degeneration.
For information on the FDA's consideration to withdraw Avastin for breast cancer:
For more information on the clinical trial comparing Avastin to Lucentis:
View all news updates for macular degeneration
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