June 26, 2011 / 4:17 PM / in 7 years

CHRONOLOGY-Key dates for Roche cancer drug Avastin

WASHINGTON, June 26 (Reuters) - Roche ROG.VX unit Genentech is appealing a U.S. proposal to withdraw breast cancer as an approved use for Avastin, the world’s best-selling cancer drug with $6 billion in annual sales. A hearing on the appeal takes place Tuesday and Wednesday.

Below is a timeline of key developments on Avastin:

February 2004: Avastin wins its first U.S. Food and Drug Administration approval, for treating colon cancer, after showing it extended survival by five months when added to chemotherapy. The drug was the first medicine to work by starving tumors of blood, a mechanism known as anti-angiogenesis.

October 2006: The FDA clears Avastin for lung cancer.

December 2007: Advisory panel votes 5-4 against recommending approval of Genentech’s application to market Avastin for breast cancer.

February 2008: FDA rejects panel advice and approves Avastin for treating breast cancer based on study that showed the drug delayed cancer growth by 5.5 months. Agency requires two follow-up studies to confirm effectiveness.

May 2009: Avastin wins U.S. approval for glioblastoma, an aggressive form of brain cancer.

August 2009: The drug is cleared for treating kidney cancer.

November 2009: Genentech submits data to the FDA from follow-up research in breast cancer. Studies show Avastin delayed cancer growth by one month to three months, a shorter period than seen in the earlier study. No studies show Avastin extends survival of breast cancer patients.

July 2010: FDA advisory panel, in a 12-1 vote, urges the agency to withdraw approval of Avastin for breast cancer, a use that generates about $1 billion of the drug’s annual sales. Panelists said Avastin did not offer enough improvement in breast cancer to justify risks such as gastrointestinal perforations, bleeding and blood clots.

December 2010: U.S. FDA proposes withdrawing approval of Avastin for breast cancer. Europe recommends restricting the drug in breast cancer so it is given with only one type of chemotherapy. Roche requests a hearing to appeal the U.S. decision.

June 2011: FDA to hold hearing on Genentech’s appeal.

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