Home » Law and Legal Articles » Breast Cancer Drug Avastin No Longer Approved to Fight Disease
Breast Cancer Drug Avastin No Longer Approved to Fight Disease
The FDA determined that the use of Avastin by breast cancer patients may do more harm than good, potentially causing hemmoraging and high blood pressure. The FDA has revoked its approval of Avastin for those fighting breast cancer.
January 22, 2012 /Law and Legal PR News/ -- The nearly 29,000 women who are diagnosed with metastatic breast cancer each year have lost one weapon they previously had to use to fight the disease. In the fall of 2011, the cancer-fighting drug Avastin had its approval for use to treat breast cancer revoked by the Food and Drug Administration (FDA).
After promising preliminary study results showed that the drug could meaningfully extend the life of women fighting breast cancer, follow up studies were unable to replicate the results. Instead, Avastin may be a highly dangerous drug for those fighting breast cancer. FDA commissioner Dr. Margaret A. Hamburg said that Avastin could expose women to potentially serious side effects -- hemorrhaging and high blood pressure.
Because Avastin treats some women's breast cancer very well, the New York Times reports that "many breast cancer specialists" believe the drug should remain available for use. In fact, because the drug works well in fighting other types of cancers, it will remain on the market. This also means that an off-label version of the drug will continue to be available for use to fight breast cancer. However, as the New York Times notes, insurers now may decline to pay for the drug if used in the treatment of breast cancer.
Accelerated Approval for Fighting Breast Cancer
A 2007 study indicated that using Avastin to treat breast cancer would extend the lives of women battling the disease by about 5.5 months. This study showed that women would experience "progression-free-survival" -- tumors neither grow nor spread -- during those months.
Based on the results of this preliminary study, the FDA gave Avastin "accelerated approval" for the treatment of breast cancer, in 2008. The FDA's accelerated approval program allows the agency to provisionally approve a drug for use without the amount of evidence of effectiveness normally required for approval.
After granting approval through the accelerated program, testing must be continued on the preliminarily approved drug to verify its effectiveness. After conducting further tests, a panel of FDA experts was unable to replicate the results of the 2007 study.
Ultimately, Avastin's use for breast cancer was revoked because the FDA panel of experts found that the drug neither extended the life of women by a "significant degree," nor did it "suppress tumor growth," according to the New York Times.
Using Avastin to Treat Other Cancers
While further tests of Avastin have not been able to replicate its initial promise in treating breast cancer, the drug has proven effective in helping patients suffering from other types of cancers. The FDA's revocation of the use of Avastin for breast cancer does not affect the drug's use in treating other forms of cancer.
When used in conjunction with chemotherapy, Avastin has been shown to add about two months to the lives of patients suffering from lung cancer, compared to the use of chemotherapy alone. Avastin extends the lives of patients suffering from renal cancer by an average of nearly five months of progression-free-survival.
Are There Other Issues With Avastin?
The FDA's revocation of the use of Avastin for treating breast cancer is not the first time the agency has had to take an action concerning the drug. Recently, the FDA issued a warning that repackaged versions of the drug had become tainted with bacteria and had led to serious eye conditions.
Many eye doctors have begun using off label Avastin to treat age-related macular degeneration, a condition that commonly leads to vision loss. While Avastin has not been approved to treat this condition, the drug has the same mode of action as the drug Lucentis (which is approved to treat macular degeneration) and off-label Avastin is significantly cheaper.
The FDA warning, which did not indicate that there were any negative issues with the drug itself, pertained to Avastin that had been repackaged into smaller, single-use doses. The FDA issued the warning after at least 16 people, many of whom were treated in Miami, developed devastating eye injuries and infection, with some resulting in blindness. One patient had the eye infection spread to his brain, which has left him with permanent brain damage.
The FDA indicated that the tainted Avastin injections could be linked back to specific pharmacies where single-use doses were packaged.
Avastin is not the only drug that may pose the risk of severe side effects; Avastin just has been in the news recently. If you have been injured due to the use of Avastin or another drug to treat cancer or another disease or condition, speak with an experienced Florida personal injury attorney.
Article provided by Friedman, Rodman & Frank, P.A.
Visit us at www.friedmanrodmanfrank.com
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