800-320-8000     

An advisory committee for the U.S. Food and Drug Administration (FDA) voted to endorse the agency’s recommendation to revoke approval of the cancer drug Avastin for breast cancer, reported the New York Times.  The unprecedented two-day appeal hearing began on Tuesday to address the FDA’s 2010 recommendation which rejected accelerated approval of the drug.

Genentech, the drug’s manufacturer, offered to conduct a final clinical trial and restrict “use of the drug to aggressive cancers or changing the drug’s label.”  However, the panel members in a 6-0 decision rejected the companies’ compromise finding Avastin was “neither safe nor effective.” [Read more...]

A recent report reveals a major study of the antiepileptic drug Neurontin was designed to generate money and not to collect data concerning patient health.  On Monday, a report published in the Archives of Internal Medicine claims drug manufacturer Parke-Davis, a subsidiary of Pfizer, initiated a 1995 study of the Neurontin with the intentions to “get more doctors to prescribe to the drug,” reported MinnPost.com.

Rather than determine the drug’s safety and effectiveness, the company conducted a “seeding trial” with the purpose to increase sales and recruit patients.  Seeding trials are not illegal just frowned upon by many health care professionals. [Read more...]

The U.S. Food and Drug Administration (FDA) will conduct an appeal hearing over the agency’s decision to revoke accelerated approval of cancer drug Avastin.  The two-day hearing commenced on Tuesday, will allow drug manufacturer Roche the chance to appeal the agency’s 2010 recommendation that revoked approval of Avastin for breast cancer.  FDA officials said Avastin for breast cancer seemed “promising but turned out to carry high risk with minimal benefits.”  The agency’s decision was based on follow-up studies results showing a minimal survival benefit and an increased risk of various side-effects.

Roche will be the first company to formally oppose FDA approval.  Officials unaffiliated with the agency will preside over the hearing and on Wednesday a panel of experts chosen by the FDA will vote on whether to affirm the agency’s recommendation.  Roche plans to argue for a final chance to conduct a clinical trial before further government action regarding Avastin.  According to the Wall Street Journal, the hearing will also affect the likelihood of future accelerated approvals of cancer drugs.

In 2008, Avastin was approved “for use in conjunction with chemotherapy under the FDA’s accelerated approval program,” reported Health Day.   The agency based approval on a single clinical trial observing patients “with metastatic HER2-negative breast cancer.”  According to the Wall Street Journal, the study was designed to demonstrate Avastin “could keep women with breast cancer tumor-free for an additional five-months.”

The results showed a benefit in terms of cancer recurrence; however, three subsequent studies failed to reveal an overall survival benefit.

Therefore, on December 16, the FDA concluded “patients receiving Avastin did not live any longer than patients not treated with the drug and were at greater risk of severe side effects, some of which are unique to Avastin,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

The December decision did not prevent Avastin from remaining on the market since it is approved for advanced colon, lung, kidney and brain cancer.  The drug can also be prescribed by physicians to treat breast cancer “even if the label is changed,” says the Wall Street Journal.

Roche claims the FDA’s understanding of Avastin is incorrect.  The company claims the drug has quality-of-life benefits even if study results do not show an overall survival benefit.  Roche is defending their product by lobbying on Capitol Hill.  The company said the FDA recommendation is the “biggest health-care story this year,” making their lobbying efforts “only natural.”

Aman Buzdar of the M.D. Anderson Cancer Center in Houston said, “Genentech is making this a political issue.  It should be decided on the science, not by lobbyists or attorneys or politicians.”

In July 2010, Buzdar was part of the FDA advisory panel that voted 12-1 to revoke Avastin’s approval for breast cancer therapy.