Avastin Legal News Articles & Interviews

Washington, DC The FDA has denied Roche, the manufacturer of Avastin, to use its top selling-cancer drug as a treatment for breast cancer therapy. The decision has ended a year-long battle between Roche, the FDA and health professionals, who argued whether Avastin’s benefits outweighed the risks.

Washington, DC In a unanimous vote late yesterday, an expert panel under the auspices of the US Food and Drug Administration (FDA) rejected a plea by pharmaceutical manufacturer Genentech to abandon the agency's intent to revoke approval of Avastin for breast cancer treatment.

Washington, DC An FDA panel reviewing the efficacy of Roche’s blockbuster cancer drug Avastin in metastatic HER2 negative breast cancer has ruled to pull the indication. The vote took place Wednesday with the Advisory panel made up of cancer specialists voting unanimously to pull the indication. The panel voted three times, and each time the vote was unanimous, ruling that the data on Avastin in this particular group of breast cancer patients is not effective, and not necessarily safe, and therefore should not be approved for treatment.

Washington, DC It's been expected—and today the manufacturer of Avastin begins a two-day appeal before the US Food and Drug Administration (FDA), pleading for more time in an attempt to save a controversial breast cancer drug.

Chicago, IL US researchers concluded recently that Roche's Avastin injection is as effective as its more expensive eye drug Lucentis in treating vision loss due to macular degeneration, but comes with more side effects.

Washington, DC Now that Avastin manufacturer Genentech has its hearing set with the US Food and Drug Administration (FDA) for June 28 and 29, the focus is on advancing its position that the FDA's proposed withdrawal of the indication for metastatic breast cancer (MBC) is not consistent with previous accelerated approvals. The FDA announced it was withdrawing its approval for MBC indication due to the results of two clinical trials that seemed to cast doubt on the safety and efficacy of Avastin for MBC. There are also concerns over Avastin side effects.

Washington, DC The US Food and Drug Administration (FDA) recently granted Swiss drugmaker Roche an opportunity to have a public hearing in defense of its Avastin injection for the treatment of breast cancer, The Associated Press reports.

Washington, DC Cancer drug Avastin, and the manufacturer's current battle with the US Food and Drug Administration (FDA) over Avastin side effects and overall effectiveness with regard to the prevention and treatment of breast cancer, echoes a similar issue from back in the spring of 2009, when pharmaceutical giant Roche purchased controlling interest in Avastin's parent, Genentech.

St. Paul, MN "In 2008 my son was diagnosed with a brain tumor," says John (not his real name). "After 31 radiation treatments the tumor was gone, but it came back and he was treated with a number of anti-cancer drugs, including Avastin." John's son lost his battle with brain cancer in October 2009. He was twelve years old.

Washington, DC Roche, the maker of Avastin, has been granted a hearing by the Food and Drug Administration, the first of its kind, in which Roche will make its case for keeping the drug's indication for breast cancer.