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Avastin Linked to Increased Risk of Death FAQ

What is Avastin?

Avastin (generic name bevacizumab ) is an anti-cancer drug used in combination with chemotherapy. Avastin is given through an infusion into a vein (intravenous, IV).

How does Avastin work?

Avastin chemotherapy inhibits tumor growth by preventing the formation of new blood vessels that then deliver oxygen and nutrients to the tumor, allowing it to grow. In other words, it prevents the tumor from signalling the body to create new blood vessels—and by blocking the creation of new blood vessels, Avastin forces tumor cells to smother and starve themselves to death.

What kinds of cancer treatment is Avastin used for?

Avastin was first approved in 2004 for patients with colon and rectal cancer, and some lung cancers. It is also used for brain cancers. Avastin eye injection is also given off-label by a number of ophthalmologists in the treatment of Avastin macular degeneration.

Specifically, Avastin treatment is used for:

• colon or rectal cancer, used as part of a combination chemotherapy regimen.
• non-squamous, non-small cell lung cancer as part of a combination chemotherapy regimen.
• part of a combination chemotherapy regimen in patients who have not received chemotherapy for metastatic breast cancer.
• glioblastoma (GBM) that has worsened following prior chemotherapy.
• the treatment of patients with metastatic renal cell carcinoma, in combination with interferon alfa

Why is Avastin no longer given to women with breast cancer?

In December 2007 an FDA expert panel rejected Avastin as an approved breast cancer treatment, after new research indicated that Avastin risks outweigh benefits in breast cancer patients. Four Avastin clinical studies showed that women who used Avastin to treat breast cancer did not prolong their overall survival rates nor provide a sufficient benefit in slowing the progression of the disease.

Some women with breast cancer, however, are willing to risk Avastin side effects where no other treatments are available. Although the FDA renounced Genentech's (Avastin manufacturer) application for metastatic breast cancer, as of December 2010 it is approved for treatment of metastatic breast cancer in Europe.

Is the FDA Avastin breast cancer decision final?

No. Although the FDA has withdrawn Avastin to treat advanced breast cancer, Genentech has an active / open application pending with the FDA for approval of Avastin as a second-line therapy (rather than first-line) for advanced breast cancer after failure of first-line therapy, and the FDA deadline for that second-line application is May 2011. Currently about 200 Avastin breast cancer clinical trials are going on worldwide.

Is Avastin eye treatment still used?

In October 2007 Genentech restricted sales of Avastin for ophthalmic uses, citing safety concerns with compounding pharmacies that have been dividing Avastin into the smaller quantities needed for treating the eye.

According to Genentech, Avastin will continue to be made available directly to physicians and hospital pharmacies through authorized wholesale distributors. However, ophthalmologists need compounding pharmacies to divide vials of Avastin into smaller doses for the treatment of AMD and other eye disorders.

What are Avastin side effects?

The most common serious Avastin side effects are internal bleeding and infection due to low white blood cell count. According to the FDA, serious Avastin side effects include severe bleeding, hemorrhage and severe high blood pressure, specifically:

• Congestive heart failure in patients who have received prior treatment with anthracycline based chemotherapy, or radiation therapy to the chest wall.
• Gastrointestinal perforation/ fistula formation/ wound healing complications
• Hemorrhage (severe bleeding)
• Hypertensive crisis (severe high blood pressure)
• Nephrotic Syndrome - a condition marked by very high levels of protein in the urine (proteinuria), low levels of protein in the blood, swelling, especially around the eyes, feet and hands. This syndrome is caused by damage to the glomeruli (tiny blood vessels in the kidney that filter waste and excess water from the blood and send them to the bladder as urine).

Is Avastin also linked to kidney damage?

Yes. Avastin may cause kidney damage, according to the Journal of the American Society of Nephrology (June 2010) Dr. Shenghong Wu and a team of scientists at Stony Brook University Medical Center found that patients on Avastin were at increased risk of severe protein loss from the kidneys, which can lead to permanent damage.

Overall, patients on Avastin were at a fourfold risk for protein loss and kidney damage, depending on dosage and the type of cancer. Ten percent of patients being treated with the drug for kidney cancer suffered organ damage and were at highest risk.

Why are there Avastin lawsuits?

While some cancer patients are given Avastin in conjunction with chemotherapy, new research indicates that, due to its potential side effects, Avastin may increase the risk of death in some cancer patients—particularly women with breast cancer-- when compared to the use of chemotherapy alone.

Avastin lawsuits are now calling for the maker of Avastin to stop marketing Avastin treatment for advanced breast cancer because studies have shown that the anti-cancer drug does not extend survival for breast cancer patients. Further, one study has shown that Avastin breast cancer patients have been linked to a risk of heart failure.

A number of Avastin personal injury lawsuits stem from other serious side effects, including:

• Changes in vision or nervous system disturbances
• Kidney dysfunction
• Reduced white blood cell count
• Severe bleeding
• Severe high blood pressure
• Slow or incomplete wound healing
• Stroke, heart attack, blood clots, chest pain
• Severe and potentially fatal condition called gastrointestinal (GI) perforation, or a hole in the stomach or intestines (rarely)